Phase 2
Completed N=55
To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants
Source: ClinicalTrials.gov NCT04914377 ↗Enrolled (actual)
55
Serious AEs
1.8%
Results posted
Aug 2024
Primary outcomePrimary: Median Time to Sustained Clinical Response — 6; 8 Days
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Sustained Clinical Response |
6; 8 | — |
| PRIMARY Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations |
4; 7 | — |
| SECONDARY Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline) |
13681.67; 9023.63 | — |
| SECONDARY Number and Percentages of Study Participants With Viral Clearance |
16; 11 | — |
| SECONDARY Severity and Change in Covid Symptoms |
12.65; 17.05; 0.54; 0.77; 0.42; 1.03 | — |
| SECONDARY Correlation Between Covid Symptoms and Viral Load |
-0.29; -0.51; -0.51; -0.53; -0.17; -0.37 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 and over, presenting with recent mild to moderate clinical symptoms of Covid-19 infection (per FDA guidance - see appendix 3)
- Positive COVID-19 infection confirmed with a rapid antigen test at screening (or RT-PCR within the last 3 days) and confirmed with a RT-PCR test at baseline
- A score of >/=3 on a minimum of 2 symptoms on the Modified FLU-PRO Plus
- Ability to take oral medication and be willing to adhere to the dosing regimen (Twice a day - BID for 14 days)
- For females of reproductive potential: negative pregnancy test at screening and use of highly effective contraception method during study participation and for an additional 4 weeks after the end of study drug administration
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Exclusion Criteria
- Current or recent (within 4 weeks) treatment with any corticosteroids; however, high-dose inhaled steroids, which are used to treat acute or chronic bronchial inflammation, will be permitted
- Current or recent (within 4 weeks) treatment with any antivirals
- Room air oxygen saturation (SaO2) 4 times the ULN); any laboratory parameter >/= 4 times the ULN
- History of moderate to severe CKD, (i.e. an estimated glomerular filtration rate less than 45 mL/min) at the time of enrollment or history of liver disease
- Patients with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of TQ Formula enteric coated capsules.
- Known HIV or Hepatitis C infection
- Influenza diagnosis (confirmed by testing) during screening or within prior 14 days
- Any uncontrolled condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation, as per investigator
- Current treatment with CYP2C9 substrates
Data sourced from ClinicalTrials.gov (NCT04914377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.