Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions (NCT NCT05592418)

Last Updated: 2025-01-22

Results Overview

Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores \<55 are within normal limits, 55-60 mild, 61-70 moderate, and \>70 severe fatigue.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Baseline and Week 13

Results posted on

2025-01-22

Participant Flow

Of 142 screened participants, 80 met inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	Ampligen / Rintatolimod Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Overall Study STARTED	40	40
Overall Study COMPLETED	36	30
Overall Study NOT COMPLETED	4	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Ampligen / Rintatolimod Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	3
Overall Study Withdrawal by Subject	2	7

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ampligen® /Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo/Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly	Total n=80 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 11.03 • n=5 Participants	34.8 years STANDARD_DEVIATION 10.08 • n=7 Participants	36.3 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Height (cm)	169.5 cm STANDARD_DEVIATION 12.97 • n=5 Participants	170.2 cm STANDARD_DEVIATION 10.15 • n=7 Participants	169.9 cm STANDARD_DEVIATION 11.58 • n=5 Participants
Weight (kg)	85.6 kg STANDARD_DEVIATION 20.95 • n=5 Participants	87.8 kg STANDARD_DEVIATION 21.72 • n=7 Participants	86.7 kg STANDARD_DEVIATION 21.23 • n=5 Participants
BMI (kg/m^2)	29.5 kg/m^2 STANDARD_DEVIATION 5.91 • n=5 Participants	30.3 kg/m^2 STANDARD_DEVIATION 7.73 • n=7 Participants	29.9 kg/m^2 STANDARD_DEVIATION 6.85 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 13

Population: The Modified Intent-to-Treat (mITT) Population defined as the set of subjects who received at least one dose of study treatment (Ampligen® or placebo).

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score) Baseline	69.9 T-Score Standard Deviation 9.31	69.4 T-Score Standard Deviation 7.51
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score) change from Baseline at week 13	-25.4 T-Score Standard Deviation 11.2	-25.8 T-Score Standard Deviation 11.85

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score) Baseline	69.9 T-Score Standard Deviation 9.31	69.4 T-Score Standard Deviation 7.51
Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score) change from baseline at week6-V12	-23.0 T-Score Standard Deviation 13.65	-19.6 T-Score Standard Deviation 15.58

SECONDARY outcome

Timeframe: Baseline to Week 6 and 13

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. For this endpoint, the last question of "How often did you have enough energy to exercise strenuously" was excluded. Therefore, the lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 33.4; the highest possible T-score is 76.8. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven Baseline	66.2 T-Score Standard Deviation 7.23	66.1 T-Score Standard Deviation 5.98
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven change from baseline at Week6-V12	-23.8 T-Score Standard Deviation 14.16	-20.8 T-Score Standard Deviation 16.89
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven change from baseline at Week13-V26	-27.1 T-Score Standard Deviation 12.37	-28.3 T-Score Standard Deviation 12.32

SECONDARY outcome

Timeframe: Baseline to week 6 and week 13

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) Baseline	317.7 Meters Standard Deviation 79.85	312.1 Meters Standard Deviation 82.86
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) Change from baseline at week6-V12	-2.1 Meters Standard Deviation 90.77	1.3 Meters Standard Deviation 87.64
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) Change from baseline at week13-V26	89.1 Meters Standard Deviation 108.18	69.3 Meters Standard Deviation 90.47

SECONDARY outcome

Timeframe: End of 12 week treatment phase

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

Percentage of subjects with increase of at least 54 m from baseline in the Six-Minute Walk Test (6MWT) at the end of 12-week treatment phase presented and summarized descriptively by treatment group.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=39 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=35 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Percentage of Subjects With Minimal Clinically Important Difference (MCID)	39 Participants	35 Participants

SECONDARY outcome

Timeframe: Baseline to Week 6 and 13

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

Change in mean cognitive function T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Cognitive Function - Abilities short form 8a that assesses self-perceived cognitive deficits. The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 23.27; the highest possible T-score is 67.09. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the better the cognitive function of the individual. Scores \>45 are within normal limits, 40-45 mild, 30-40 moderate, and \<30 severe cognitive dysfunction.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score). Baseline	50.0 T-Score Standard Deviation 11.67	46.3 T-Score Standard Deviation 10.31
Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score). Change from Baseline to week6-V12	5.5 T-Score Standard Deviation 15.17	8.6 T-Score Standard Deviation 15.16
Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score). Change from baseline to week13-V26	2.8 T-Score Standard Deviation 18.63	8.0 T-Score Standard Deviation 18.08

SECONDARY outcome

Timeframe: Baseline to Week 6 and 13

Population: All Modified Intent to Treat (mITT) Population

Change in mean sleep disturbance T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance - short form 4a that assesses self-perceived sleep quality. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 32; the highest possible T-score is 73.3. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the sleep disturbance of the individual. Scores \<55 are within normal limits, 55-60 mild, 61-70 moderate, and \>70 severe fatigue.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score) Baseline	48.3 T-Score Standard Deviation 7.99	48.4 T-Score Standard Deviation 8.89
Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score) Change from baseline at Week6-V12	-10.9 T-Score Standard Deviation 7.45	-5.6 T-Score Standard Deviation 9.21
Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score) change from baseline at Week13-V26	-12.1 T-Score Standard Deviation 7.95	-10.7 T-Score Standard Deviation 8.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and the end of treatment phase at week 12

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

The SBQ-LC (Symptom Burden Questionnaire for Long COVID), which includes questions related to common COVID-19 symptoms, was assessed at baseline and at every odd-numbered visit from Visit 3 to Visit 25. Data at baseline and change from baseline at Week 12 (end of treatment) is reported. The converted scores reported for each symptom range from 0 to 100, with a higher score indicating worse symptom burden.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from Baseline at week12: Pain Scale	-3.2 units on a scale Standard Deviation 8.94	-4.1 units on a scale Standard Deviation 8.13
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Skin & Hair	10.9 units on a scale Standard Deviation 14.32	12.2 units on a scale Standard Deviation 20.13
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from baseline at week12: Skin & Hair	-8.2 units on a scale Standard Deviation 13.05	-3.8 units on a scale Standard Deviation 9.53
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Sleep Scale	31.0 units on a scale Standard Deviation 31.68	35.1 units on a scale Standard Deviation 30.53
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from Baseline at week12: Sleep Scale	-18.4 units on a scale Standard Deviation 30.99	-23.8 units on a scale Standard Deviation 28.27
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Stomach & Digestion	6.6 units on a scale Standard Deviation 12.71	10.1 units on a scale Standard Deviation 14.83
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline : Breathing	21.5 units on a scale Standard Deviation 14.28	23.7 units on a scale Standard Deviation 16.97
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Mean change from baseline at week12 : Breathing	-19.2 units on a scale Standard Deviation 14.43	-18.3 units on a scale Standard Deviation 12.70
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline : Circulation	9.4 units on a scale Standard Deviation 17.08	14.3 units on a scale Standard Deviation 20.94
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Mean change from baseline at week12 : Circulation	-6.4 units on a scale Standard Deviation 13.72	-9.0 units on a scale Standard Deviation 12.61
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline : Ear, Nose, and Throat	9.5 units on a scale Standard Deviation 14.09	14.3 units on a scale Standard Deviation 17.50
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Mean change from baseline at week12 : Ear, Nose, and Throat	-5.4 units on a scale Standard Deviation 12.73	-10.3 units on a scale Standard Deviation 14.26
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Eyes	8.8 units on a scale Standard Deviation 14.63	13.5 units on a scale Standard Deviation 19.25
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. change from baseline to week12 : Eyes	-3.9 units on a scale Standard Deviation 10.04	-4.7 units on a scale Standard Deviation 10.64
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline Fatigue converted score	28.1 units on a scale Standard Deviation 24.28	32.4 units on a scale Standard Deviation 27.87
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. change from baseline at week12 for fatigue score	-22.0 units on a scale Standard Deviation 21.47	-19.4 units on a scale Standard Deviation 23.06
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Female Repro.& Sex Health	4.6 units on a scale Standard Deviation 10.72	4.3 units on a scale Standard Deviation 6.77
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. change from baseline at week 12; Female Repro.& Sex Health	-2.8 units on a scale Standard Deviation 12.60	-1.8 units on a scale Standard Deviation 6.85
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Impact on Daily Life Scale	13.7 units on a scale Standard Deviation 20.99	18.1 units on a scale Standard Deviation 24.01
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from basline at week 12: Impact on Daily Life Scale	-9.2 units on a scale Standard Deviation 16.75	-8.9 units on a scale Standard Deviation 15.18
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline:Male Repro.&Sex Health	12.2 units on a scale Standard Deviation 26.16	11.7 units on a scale Standard Deviation 21.29
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. change from baseline at week 12: Male Reproductive and Sexual Health	-3.2 units on a scale Standard Deviation 21.06	-11.3 units on a scale Standard Deviation 20.47
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Memory,Thinking&Commun.	13.7 units on a scale Standard Deviation 18.66	20.0 units on a scale Standard Deviation 23.64
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from baseline to week 12; Memory,Thinking&Commun.	-7.5 units on a scale Standard Deviation 14.59	-9.9 units on a scale Standard Deviation 20.23
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: MentalHealth & Wellbeing	28.2 units on a scale Standard Deviation 4.83	27.0 units on a scale Standard Deviation 7.22
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from Baseline: MentalHealth & Wellbeing	-17.1 units on a scale Standard Deviation 11.52	-13.0 units on a scale Standard Deviation 16.48
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Movement	10.8 units on a scale Standard Deviation 23.02	11.8 units on a scale Standard Deviation 25.39
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from baseline at week 12: Movement	-5.5 units on a scale Standard Deviation 15.48	-3.5 units on a scale Standard Deviation 8.68
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Muscle & Joints	11.5 units on a scale Standard Deviation 15.73	15.2 units on a scale Standard Deviation 22.09
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. change from baseline at week 12: Muscle & Joints	-7.3 units on a scale Standard Deviation 11.77	-6.1 units on a scale Standard Deviation 12.09
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Other Symptoms	10.9 units on a scale Standard Deviation 13.75	13.2 units on a scale Standard Deviation 15.64
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from baseline at week 12: Other Symptoms	-8.1 units on a scale Standard Deviation 11.29	-7.9 units on a scale Standard Deviation 11.72
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Baseline: Pain Scale	5.5 units on a scale Standard Deviation 9.45	7.4 units on a scale Standard Deviation 14.53
Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. Change from Baseline: Stomach & Digestion	-4.0 units on a scale Standard Deviation 12.21	-4.7 units on a scale Standard Deviation 9.03

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to weeks 4, 8 and 13 during treatment phase

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects whohave received at least one dose of study treatment (Ampligen® or placebo).

The change from baseline in Montreal Cognitive Assessment (MoCA) at week 4, 8, and 13 is presented and summarized descriptively by treatment group. Higher scores indicate better cognitive function; total scores equal to or higher than 26 are considered normal. Montreal Cognitive Assessment range is from 0-30, with a score of 26 or higher indicating normal cognitive function. 18-25 indicates mild cognitive impairment; 10-17 indicates moderate cognitive impairment; less than 10 indicates severe cognitive impairment.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline in Cognitive Function as Measured by Montreal Cognitive Assessment (MoCA) at Weeks 4, 8, and 13 During the Treatment Phase Baseline	27.7 score on a scale Standard Deviation 2.04	28.1 score on a scale Standard Deviation 2.06
Change From Baseline in Cognitive Function as Measured by Montreal Cognitive Assessment (MoCA) at Weeks 4, 8, and 13 During the Treatment Phase change from baseline at Week 4 - V8	-0.6 score on a scale Standard Deviation 3.61	-0.1 score on a scale Standard Deviation 2.8
Change From Baseline in Cognitive Function as Measured by Montreal Cognitive Assessment (MoCA) at Weeks 4, 8, and 13 During the Treatment Phase change from baseline at Week 8 - v16	-0.1 score on a scale Standard Deviation 2.75	-0.2 score on a scale Standard Deviation 3.14
Change From Baseline in Cognitive Function as Measured by Montreal Cognitive Assessment (MoCA) at Weeks 4, 8, and 13 During the Treatment Phase change from baseline at Week 13 - V26	0.8 score on a scale Standard Deviation 2.26	0.5 score on a scale Standard Deviation 2.11

OTHER_PRE_SPECIFIED outcome

Timeframe: During the treatment phase up to 12 weeks

Population: all Modified Intent-to-Treat population subjects

Number of subjects with hospitalization during treatment phase up to week 12.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Hospitalizations	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During the treatment phase up to 12 weeks

Population: No patients were hospitalized.

Duration (days) of hospitalization during the treatment phase up to week 12.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 6 and 13

Population: all Modified Intent-to-Treat population subjects

A blood sample was collected at V2 (pre-dose), V12 (pre-dose), and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of lymphocyte profile by flow cytometry. The absolute values and change from baseline data for CD3+ were evaluated.

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3+ Baseline	1598.4 CD3+ cells/μL Standard Deviation 573.79	1739.4 CD3+ cells/μL Standard Deviation 637.33
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3+ Change from Baseline to Week6-V12	-54.1 CD3+ cells/μL Standard Deviation 756.11	-71.8 CD3+ cells/μL Standard Deviation 389.79
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3+ Change from Baseline to Week13-V26	65.8 CD3+ cells/μL Standard Deviation 532.92	-196.3 CD3+ cells/μL Standard Deviation 324.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 6 and 13

Population: all Modified Intent-to-Treat population subjects

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3-CD56+ Natural Kill Baseline	252.5 CD3-CD56+ Natural Killer cells/μL Standard Deviation 120.11	235.1 CD3-CD56+ Natural Killer cells/μL Standard Deviation 113.55
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3-CD56+ Natural Kill Change from Baseline to Week6-V12	-27.2 CD3-CD56+ Natural Killer cells/μL Standard Deviation 137.66	-28.3 CD3-CD56+ Natural Killer cells/μL Standard Deviation 116.7
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3-CD56+ Natural Kill Change from Baseline to Week13-V26	-27.9 CD3-CD56+ Natural Killer cells/μL Standard Deviation 75.45	25.4 CD3-CD56+ Natural Killer cells/μL Standard Deviation 215.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 6 and 13

Population: all Modified Intent-to-Treat population subjects

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=40 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - CD4:CD8 Ratio Baseline	1.7 CD4:CD8 Ratio Standard Deviation 0.7	1.6 CD4:CD8 Ratio Standard Deviation 0.58
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - CD4:CD8 Ratio Change from Baseline to Week6-V12	0.0 CD4:CD8 Ratio Standard Deviation 0.36	0.0 CD4:CD8 Ratio Standard Deviation 0.28
Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - CD4:CD8 Ratio Change from Baseline to Week13-V26	0.2 CD4:CD8 Ratio Standard Deviation 0.48	0.0 CD4:CD8 Ratio Standard Deviation 0.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and week 13

A blood sample was collected at V2 (pre-dose) and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of protein biomarkers.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: Baseline to week 6 and week 13

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=35 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=35 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking ≥205 Meters at Baseline Baseline	337.3 Meters Standard Deviation 63.79	328.9 Meters Standard Deviation 74.3
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking ≥205 Meters at Baseline Change from baseline at week6-V12	-21.8 Meters Standard Deviation 72.65	-9.3 Meters Standard Deviation 89.39
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking ≥205 Meters at Baseline Change from baseline at week13-V26	81.3 Meters Standard Deviation 114.37	64.9 Meters Standard Deviation 98.2

POST_HOC outcome

Timeframe: Baseline to week 6 and week 13

Population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo).

Outcome measures

Outcome measures
Measure	Ampligen / Rintatolimod n=5 Participants Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=5 Participants Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking <205 Meters at Baseline Baseline	180.0 Meters Standard Deviation 22.45	194.4 Meters Standard Deviation 15.65
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking <205 Meters at Baseline Change from baseline at week6-V12	123.6 Meters Standard Deviation 101.96	63.0 Meters Standard Deviation 43.06
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking <205 Meters at Baseline Change from baseline at week13-V26	139.2 Meters Standard Deviation 18.2	91.2 Meters Standard Deviation 27.63

Adverse Events

Ampligen / Rintatolimod

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo / Saline

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Diane Young

AIM ImmunoTech Inc.

Phone: 352-448-7797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Other adverse events
Measure	Ampligen / Rintatolimod n=40 participants at risk Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly	Placebo / Saline n=40 participants at risk Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly
Skin and subcutaneous tissue disorders Pruritus	5.0% 2/40 • Number of events 3 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Urticaria	5.0% 2/40 • Number of events 2 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Alopecia	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Paraesthesia	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Feeling abnormal	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Injection site pain	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Injection site phlebitis	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Pyrexia	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Nervous system disorders Migraine	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Nervous system disorders Tremor	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations COVID-19	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Pharyngitis streptococcal	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Investigations Alanine aminotransferase increased	5.0% 2/40 • Number of events 2 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Investigations Aspartate aminotransferase increased	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Investigations Blood creatine phosphokinase increased	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Psychiatric disorders Anxiety	5.0% 2/40 • Number of events 2 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Vascular disorders Hot flush	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Vascular disorders Peripheral coldness	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Ear and labyrinth disorders Eustachian tube obstruction	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Toothache	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/40 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	2.5% 1/40 • Number of events 1 • 14 weeks AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.