Trial Outcomes & Findings for Estradiol and Progesterone in Hospitalized COVID-19 Patients (NCT NCT04865029)
NCT ID: NCT04865029
Last Updated: 2023-06-27
Results Overview
The proportion will be calculated based on WHO ordinal scale for clinical improvement. The scale is from 0 to 8, with a higher score indicating worse clinical status. * Uninfected: No clinical or virological evidence of infection 0 * Ambulatory: No limitation of activities 1 Limitation of activities 2 * Hospitalized Mild Disease Hospitalized, no oxygen therapy 3 Oxygen by mask or nasal prongs 4 * Hospitalized Severe Disease Non-invasive ventilation or high flow oxygen 5 Intubation and mechanical ventilation 6 Ventilation + additional organ support - 7 pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) * Dead Death 8
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
At discharge, measured up to Day 21
Results posted on
2023-06-27
Participant Flow
Participant milestones
| Measure |
Estradiol and Progesterone Arm
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) Corona Virus Disease (COVID-19) Treatment Guidelines
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Estradiol and Progesterone in Hospitalized COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
51.4 Years
STANDARD_DEVIATION 12.92 • n=5 Participants
|
45.6 Years
STANDARD_DEVIATION 13.41 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 12.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Body Mass Index
|
24.5 Kg/m^2
STANDARD_DEVIATION 5.47 • n=5 Participants
|
38.76 Kg/m^2
STANDARD_DEVIATION 6.87 • n=7 Participants
|
31.63 Kg/m^2
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Smoking status
Smokers
|
4 partipants
n=5 Participants
|
2 partipants
n=7 Participants
|
6 partipants
n=5 Participants
|
|
Smoking status
Non smokers
|
1 partipants
n=5 Participants
|
3 partipants
n=7 Participants
|
4 partipants
n=5 Participants
|
|
Systolic Blood pressure
|
140.8 mmHg
STANDARD_DEVIATION 18.21 • n=5 Participants
|
139.4 mmHg
STANDARD_DEVIATION 18.97 • n=7 Participants
|
140.1 mmHg
STANDARD_DEVIATION 17.54 • n=5 Participants
|
|
Diastolic blood pressure
|
91 mmHg
STANDARD_DEVIATION 18 • n=5 Participants
|
75.6 mmHg
STANDARD_DEVIATION 14.76 • n=7 Participants
|
83.3 mmHg
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Heart rate
|
94.2 Beats per minute (Bpm)
STANDARD_DEVIATION 14.67 • n=5 Participants
|
97.6 Beats per minute (Bpm)
STANDARD_DEVIATION 10.19 • n=7 Participants
|
95.9 Beats per minute (Bpm)
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
O2 saturation
|
93 Percentage of O2 saturation
STANDARD_DEVIATION 4.8 • n=5 Participants
|
88.4 Percentage of O2 saturation
STANDARD_DEVIATION 5.18 • n=7 Participants
|
90.7 Percentage of O2 saturation
STANDARD_DEVIATION 5.29 • n=5 Participants
|
|
Temperature
|
98.38 Fahrenheit
STANDARD_DEVIATION 1.33 • n=5 Participants
|
100.26 Fahrenheit
STANDARD_DEVIATION 1.07 • n=7 Participants
|
99.32 Fahrenheit
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
World Health Organization (WHO) Score of 3 to 5 at randomization
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Aspartate aminotransferase (AST)
|
78.8 Units/L
STANDARD_DEVIATION 74.97 • n=5 Participants
|
78.2 Units/L
STANDARD_DEVIATION 61.22 • n=7 Participants
|
78.5 Units/L
STANDARD_DEVIATION 64.53 • n=5 Participants
|
|
Alanine transaminase (ALT)
|
62.6 Units/L
STANDARD_DEVIATION 60.01 • n=5 Participants
|
70.2 Units/L
STANDARD_DEVIATION 47.52 • n=7 Participants
|
66.4 Units/L
STANDARD_DEVIATION 51.19 • n=5 Participants
|
|
Neutrophil lymphocyte ratio (NLR)
|
3.96 Ratio
STANDARD_DEVIATION 0.86 • n=5 Participants
|
3.85 Ratio
STANDARD_DEVIATION 2.61 • n=7 Participants
|
3.90 Ratio
STANDARD_DEVIATION 1.84 • n=5 Participants
|
|
White blood Cells (WBC)
|
6.62 10^9 cells per liter.
STANDARD_DEVIATION 0.72 • n=5 Participants
|
6.38 10^9 cells per liter.
STANDARD_DEVIATION 1.91 • n=7 Participants
|
6.5 10^9 cells per liter.
STANDARD_DEVIATION 1.37 • n=5 Participants
|
|
Platelet count
|
260 10^9 cells per liter
STANDARD_DEVIATION 66.49 • n=5 Participants
|
157.8 10^9 cells per liter
STANDARD_DEVIATION 39.88 • n=7 Participants
|
208.9 10^9 cells per liter
STANDARD_DEVIATION 74.65 • n=5 Participants
|
|
Charlson Comorbidity Index (CCI)
|
2.4 units on a scale
STANDARD_DEVIATION 1.82 • n=5 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.34 • n=7 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: At discharge, measured up to Day 21Population: Number of participants who achieved WHO score of 1 to 2 at discharge, measured up to Day 21
The proportion will be calculated based on WHO ordinal scale for clinical improvement. The scale is from 0 to 8, with a higher score indicating worse clinical status. * Uninfected: No clinical or virological evidence of infection 0 * Ambulatory: No limitation of activities 1 Limitation of activities 2 * Hospitalized Mild Disease Hospitalized, no oxygen therapy 3 Oxygen by mask or nasal prongs 4 * Hospitalized Severe Disease Non-invasive ventilation or high flow oxygen 5 Intubation and mechanical ventilation 6 Ventilation + additional organ support - 7 pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) * Dead Death 8
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Number of Participants With Scores 1 or 2 on the 9-point World Health Organization (WHO) Ordinal Scale at Discharge, Measured up to Day 21
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 60Population: Medical records were reviewed at admission to day 60 to determine length of stay.
The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on length of hospital stay.
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Length of Hospital Stay
|
7.2 Days
Standard Deviation 5.18
|
10.2 Days
Standard Deviation 7.53
|
SECONDARY outcome
Timeframe: Baseline to day 60Population: Medical records were reviewed from baseline to day 60 to determine readmission status
The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the readmission rates.
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Readmission
COVID related readmission number
|
0 participants
|
0 participants
|
|
Readmission
Non-COVID related readmission number
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to day 60Population: Medical records were reviewed baseline to day 60 to determine number of patients requiring invasive mechanical ventilation
The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the number of patients requiring invasive mechanical ventilation
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Number of Patients Requiring Invasive Mechanical Ventilation
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 60Population: Medical records were reviewed from baseline to day 60 to determine the number of days death occurred after admission. One person died on day 19 after admission in the control arm.
The investigators will review patients' medical records on day 14 and day 28 and calculate number of deaths that occurred after admission. Then, the investigators will call patients on day 60. This will be done to determine the number of days death occurred after admission.
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=1 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Number of Days Death Occurred After Admission
|
19 Days
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 60Population: Medical records were reviewed from baseline to day 60 to determine the cause of death that occurred after admission for all 10 participants.
The investigators will review patients' medical records on day 14 and day 28 and determine the cause of death. Then, the investigators will call patients on day 60. This will be done to determine the cause of death.
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Number of Participants With Each Cause of Death
Death from COVID-19
|
0 participants
|
0 participants
|
|
Number of Participants With Each Cause of Death
Death from bacteremia
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to day 60Population: Subjects were followed daily for 7 days after initiation of treatment for adverse events. Medical records were reviewed from baseline to day 60 to determine frequency and severity of adverse events in treatment arm vs. control arm.
Subjects will be followed daily for 7 days after initiation of treatment for adverse events. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency and severity of adverse events in treatment arm vs. control arm.
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Grade 3 Adverse Events Occurrence
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 60Population: Subjects were followed daily for 7 days after initiation of treatment for serious adverse events. Medical records were reviewed from baseline to day 60 to determine frequency of serious adverse events in treatment arm vs. control arm.
Subjects will be followed daily for 7 days after initiation of treatment for serious adverse events. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency of serious adverse events in treatment arm vs. control arm.
Outcome measures
| Measure |
Estradiol and Progesterone Arm
n=5 Participants
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 Participants
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Serious Adverse Events Occurrence
|
0 Participants
|
1 Participants
|
Adverse Events
Estradiol and Progesterone Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline and Folic Acid Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Estradiol and Progesterone Arm
n=5 participants at risk
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 participants at risk
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Blood and lymphatic system disorders
Death
|
0.00%
0/5 • Baseline to 60 days.
|
20.0%
1/5 • Number of events 1 • Baseline to 60 days.
|
Other adverse events
| Measure |
Estradiol and Progesterone Arm
n=5 participants at risk
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
Estradiol Cypionate 5 mg/ml: Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
Progesterone 200 mg Oral Capsule: Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Normal Saline and Folic Acid Arm
n=5 participants at risk
Standard of Care along with placebo-equivalent injection (1mL Normal Saline intramuscular injection) at admission and placebo-equivalent pill (folic acid 400 mg pill) daily for 5 days starting at admission.
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines.
Placebo injection and placebo pill: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombophlebitis
|
0.00%
0/5 • Baseline to 60 days.
|
20.0%
1/5 • Number of events 1 • Baseline to 60 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place