This is a randomized (1:1), double-blind, placebo-controlled phase 2 study to assess safety and efficacy of Total TQ Formula (3 g daily dose of Nigella Sativa Oil) capsules versus placebo in treating patients who have tested positive for novel Coronavirus 2019 (Covid-19) in the outpatient setting. Patients will be treated at a dose of 500 mg, 3 capsules, two times a day for 14 days from date of randomization. Quantitative viral load as measured by RT-PCR will be evaluated at baseline and on days 7 and 14. Covid-19 symptoms will be measured throughout the study using Modified FLU-PRO Plus.
Study Population: Up to 60 participants will be randomized 1:1 to receive either TQ Formula Capsules + Standard of Care (SOC) or placebo +SOC Phase: Phase II Approximately 2-4 centers in the United States TQ Formula (Nigella Sativa) 500 mg, 3 capsules, BID, taken orally Study Duration: 6 months Participant Duration: Up to 45 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
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).
Respire Research
San Diego, California, United States
L & A Morales Healthcare
Hialeah, Florida, United States
United Memorial Medical Center
Houston, Texas, United States
Median Time to Sustained Clinical Response
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.
Time frame: 21 Days
Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations
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.
Time frame: From the date of randomization up to Last Visit date on Day-45
Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)
Measurement 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.
Time frame: 14 Days
Number and Percentages of Study Participants With Viral Clearance
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
Time frame: 14 Days
Severity and Change in Covid Symptoms
Measurement 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.
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Time frame: 14 Days
Correlation Between Covid Symptoms and Viral Load
Correlation 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
Time frame: 14 Days