Trial Outcomes & Findings for To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants (NCT NCT04914377)
NCT ID: NCT04914377
Last Updated: 2024-08-14
Results Overview
Measurement of the difference in median time to sustained clinical response in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo. Sustained clinical response is defined as a reduction of scores to \</= 2 on all symptoms of the Modified FLU-PRO Plus.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
21 Days
Results posted on
2024-08-14
Participant Flow
Participant milestones
| Measure |
Active Drug
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
26
|
|
Overall Study
COMPLETED
|
29
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants
Baseline characteristics by cohort
| Measure |
Active Drug
n=29 Participants
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=26 Participants
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.48 years
STANDARD_DEVIATION 19.29 • n=5 Participants
|
45.92 years
STANDARD_DEVIATION 15.27 • n=7 Participants
|
45.69 years
STANDARD_DEVIATION 17.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 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 (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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 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
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Baseline Viral Load assessment
|
16499 Copies per mililiter of blood
STANDARD_DEVIATION 10712 • n=5 Participants
|
15418 Copies per mililiter of blood
STANDARD_DEVIATION 11465 • n=7 Participants
|
16002 Copies per mililiter of blood
STANDARD_DEVIATION 10964 • n=5 Participants
|
PRIMARY outcome
Timeframe: 21 DaysMeasurement of the difference in median time to sustained clinical response in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo. Sustained clinical response is defined as a reduction of scores to \</= 2 on all symptoms of the Modified FLU-PRO Plus.
Outcome measures
| Measure |
Active Drug
n=29 Participants
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=26 Participants
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Median Time to Sustained Clinical Response
|
6 Days
Interval 4.0 to 14.0
|
8 Days
Interval 5.0 to 11.0
|
PRIMARY outcome
Timeframe: From the date of randomization up to Last Visit date on Day-45Population: This analysis population includes all patients enrolled, randomized, and received at least one dose of the assigned treatment.
Number of overall adverse events, related adverse reactions, and hospitalizations reported in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo. All AEs/SAEs will be captured throughout the study as per schedule of assessments.
Outcome measures
| Measure |
Active Drug
n=29 Participants
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=26 Participants
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 14 DaysMeasurement of change in quantitative viral load from baseline to Day 14 using RT-PCR (day-14 minus baseline) in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo with COVID-19 infection.
Outcome measures
| Measure |
Active Drug
n=26 Participants
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=23 Participants
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)
|
13681.67 copies/mL
Standard Error 13169.47
|
9023.63 copies/mL
Standard Error 15350.44
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Patients who had RT-PCR test on Day-14 that was not indeterminate
Percentage of negative/undetectable RT-PCR (i.e., viral clearance) on Day-14 in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo
Outcome measures
| Measure |
Active Drug
n=21 Participants
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=19 Participants
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Number and Percentages of Study Participants With Viral Clearance
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 14 DaysMeasurement of severity of, and change in, Covid-19 symptoms per total score as well as sub-scores (Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic, Taste/Smell) measured through Modified FLU-PRO Plus from Day 1 through Day 14 in participants with COVID-19 infection treated either with 3 g TQ Formula (500 mg per capsule, 3 capsules BID) or placebo. 1. Total Symptom Score is based on 24 questions with a possible range 0-96 2. Nose Symptom Score is based on a single question with a possible scale 0-4 3. Throat Throat Symptom is based on 2 questions with a possible scale 0-8 4. Respiratory Symptom is based on 7 questions with a possible scale 0-28 5. GI symptom score is based on 4 questions with a possible scale 0-16 6. Body/Systemic Symptom Score is based on 8 questions with a possible scale 0-32 7. Smell/Taste Symptom Score is based on 2 questions with a possible scale 0-8 In each of these scales, higher scores mean higher symptom burden.
Outcome measures
| Measure |
Active Drug
n=29 Participants
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=26 Participants
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Severity and Change in Covid Symptoms
Total Symptom Burden within the first 14 days based on 24 questions on a possible scale of 0 to 96
|
12.65 Score on a scale
Standard Deviation 8.78
|
17.05 Score on a scale
Standard Deviation 8.78
|
|
Severity and Change in Covid Symptoms
Nose Symptom Burden within the first 14 days based on 1 question on a possible scale of 0 to 4
|
0.54 Score on a scale
Standard Deviation 0.55
|
0.77 Score on a scale
Standard Deviation 0.55
|
|
Severity and Change in Covid Symptoms
Throat Symptom Burden within the first 14 days based on 2 questions on a possible scale of 0 to 8
|
0.42 Score on a scale
Standard Deviation 0.52
|
1.03 Score on a scale
Standard Deviation 1.55
|
|
Severity and Change in Covid Symptoms
Respiratory Symptom Burden in the first 14 days based on 7 questions on a possible scale of 0 to 28
|
3.48 Score on a scale
Standard Deviation 4.26
|
4.65 Score on a scale
Standard Deviation 4.78
|
|
Severity and Change in Covid Symptoms
GI Symptom Burden within the first 14 days based on 4 questions on a possible scale of 0 to 16
|
0.91 Score on a scale
Standard Deviation 1.10
|
1.48 Score on a scale
Standard Deviation 1.72
|
|
Severity and Change in Covid Symptoms
Body/systemic Sympt. Burden in the first 14 days based on 8 questions on a possible scale of 0 to 32
|
6.10 Score on a scale
Standard Deviation 4.34
|
7.08 Score on a scale
Standard Deviation 5.18
|
|
Severity and Change in Covid Symptoms
Smell/Taste Sympt. Burden in the first 14 days based on 2 questions on a possible scale of 0 to 8
|
1.19 Score on a scale
Standard Deviation 1.47
|
2.03 Score on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: 14 DaysCorrelation Coefficient of quantitative viral load and symptom severity at baseline, at Day 7, and Day 14 in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo
Outcome measures
| Measure |
Active Drug
n=29 Participants
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=26 Participants
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Correlation Between Covid Symptoms and Viral Load
Day-14
|
-0.17 Correlation Coefficient
Interval -0.57 to 0.29
|
-0.37 Correlation Coefficient
Interval -0.72 to 0.13
|
|
Correlation Between Covid Symptoms and Viral Load
Baseline
|
-0.29 Correlation Coefficient
Interval -0.61 to 0.12
|
-0.51 Correlation Coefficient
Interval -0.78 to -0.08
|
|
Correlation Between Covid Symptoms and Viral Load
Day-7
|
-0.51 Correlation Coefficient
Interval -0.77 to -0.12
|
-0.53 Correlation Coefficient
Interval -0.8 to -0.09
|
Adverse Events
Active Drug
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Drug
n=29 participants at risk
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=26 participants at risk
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic Respiratory Failure Secondary to COVID Pneumonia
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
Other adverse events
| Measure |
Active Drug
n=29 participants at risk
Capsules containing TQ Formula
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
Placebo
n=26 participants at risk
Capsules containing corn oil
TQ Formula/Tab: TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough after medication. Led to chest pain
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.4%
1/29 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
0.00%
0/26 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
General disorders
Sharp chest pain
|
3.4%
1/29 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
0.00%
0/26 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Infections and infestations
Submandibular abscess
|
3.4%
1/29 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
0.00%
0/26 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Respiratory, thoracic and mediastinal disorders
couhing
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Gastrointestinal disorders
diarrhea
|
3.4%
1/29 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
7.7%
2/26 • Number of events 2 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Respiratory, thoracic and mediastinal disorders
dry or hacking cough
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Nervous system disorders
sleeping more than usual
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
Musculoskeletal and connective tissue disorders
upper back pain
|
3.4%
1/29 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
0.00%
0/26 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
|
General disorders
weak
|
0.00%
0/29 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
3.8%
1/26 • Number of events 1 • From the date of Randomization up to the last visit date on Day-45
The trial used CTCAE V5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor will be responsible for developing publication procedures and resolving authorship issues. Please refer to your specific contract, grant, and/or Clinical Trials Agreements.
- Publication restrictions are in place
Restriction type: OTHER