NCT04914377: BOSS

To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants

Completed Phase 2 Results posted Last updated 14 August 2024

What this trial tests

Phase 2 trial testing TQ Formula/Tab in Covid19 in 55 participants. Completed in 1 January 2022.

Timeline

8 June 2021

Primary endpoint
16 December 2021

1 January 2022

Quick facts

Lead sponsor	Novatek Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	55
Start date	8 June 2021
Primary completion	16 December 2021
Estimated completion	1 January 2022
Sites	3 locations across United States

Drugs / interventions tested

• TQ Formula/Tab — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Novatek Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Time to Sustained Clinical Response Primary · 21 Days

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.

Group	Value	95% CI
Active Drug	6	4 – 14
Placebo	8	5 – 11

Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations Primary · From the date of randomization up to Last Visit date on Day-45

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.

Group	Value	95% CI
Active Drug	4
Placebo	7

Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline) Secondary · 14 Days

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.

Group	Value	95% CI
Active Drug	13681.67	± 13169.47
Placebo	9023.63	± 15350.44

Number and Percentages of Study Participants With Viral Clearance Secondary · 14 Days

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

Group	Value	95% CI
Active Drug	16
Placebo	11

Severity and Change in Covid Symptoms Secondary · 14 Days

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

Total Symptom Burden within the first 14 days based on 24 questions on a possible scale of 0 to 96

Group	Value	95% CI
Active Drug	12.65	± 8.78
Placebo	17.05	± 8.78

Nose Symptom Burden within the first 14 days based on 1 question on a possible scale of 0 to 4

Group	Value	95% CI
Active Drug	0.54	± 0.55
Placebo	0.77	± 0.55

Throat Symptom Burden within the first 14 days based on 2 questions on a possible scale of 0 to 8

Group	Value	95% CI
Active Drug	0.42	± 0.52
Placebo	1.03	± 1.55

Respiratory Symptom Burden in the first 14 days based on 7 questions on a possible scale of 0 to 28

Group	Value	95% CI
Active Drug	3.48	± 4.26
Placebo	4.65	± 4.78

GI Symptom Burden within the first 14 days based on 4 questions on a possible scale of 0 to 16

Group	Value	95% CI
Active Drug	0.91	± 1.10
Placebo	1.48	± 1.72

Body/systemic Sympt. Burden in the first 14 days based on 8 questions on a possible scale of 0 to 32

Group	Value	95% CI
Active Drug	6.10	± 4.34
Placebo	7.08	± 5.18

Smell/Taste Sympt. Burden in the first 14 days based on 2 questions on a possible scale of 0 to 8

Group	Value	95% CI
Active Drug	1.19	± 1.47
Placebo	2.03	± 2.09

Correlation Between Covid Symptoms and Viral Load Secondary · 14 Days

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

Baseline

Group	Value	95% CI
Active Drug	-0.29	-0.61 – 0.12
Placebo	-0.51	-0.78 – -0.08

Day-7

Group	Value	95% CI
Active Drug	-0.51	-0.77 – -0.12
Placebo	-0.53	-0.80 – -0.09

Day-14

Group	Value	95% CI
Active Drug	-0.17	-0.57 – 0.29
Placebo	-0.37	-0.72 – 0.13

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of Randomization up to the last visit date on Day-45. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Drug

Serious: 0/29 (0%)

Deaths: 0/29

Placebo

Serious: 1/26 (4%)

Deaths: 0/26

Serious adverse events (1 terms)

Reaction	System	Active Drug	Placebo
Hypoxic Respiratory Failure Secondary to COVID Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Active Drug	Placebo
diarrhea	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Cough after medication. Led to chest pain	Respiratory, thoracic and mediastinal disorders	—	—
Flank pain	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Sharp chest pain	General disorders	—	—
Submandibular abscess	Infections and infestations	—	—
couhing	Respiratory, thoracic and mediastinal disorders	—	—
dry or hacking cough	Respiratory, thoracic and mediastinal disorders	—	—
sleeping more than usual	Nervous system disorders	—	—
upper back pain	Musculoskeletal and connective tissue disorders	—	—
weak	General disorders	—	—

Most-reported serious reactions: Hypoxic Respiratory Failure Secondary to COVID Pneumonia.

Data from ClinicalTrials.gov NCT04914377 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. <i>Nigella sativa</i>: A Comprehensive Review of Its Therapeutic Potential, Pharmacological Properties, and Clinical Applications.
   Alberts A, Moldoveanu ET, Niculescu AG, Grumezescu AM. · · 2024 · cited 12× · PMID 39769174 · DOI 10.3390/ijms252413410
2. <i>Nigella sativa</i> L. and COVID-19: A Glance at The Anti-COVID-19 Chemical Constituents, Clinical Trials, Inventions, and Patent Literature.
   Imran M, Khan SA, Abida, Alshammari MK, et al · · 2022 · cited 10× · PMID 35566101 · DOI 10.3390/molecules27092750
3. A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2.
   Bencheqroun H, Ahmed Y, Kocak M, Villa E, et al · · 2022 · cited 4× · PMID 35631072 · DOI 10.3390/pathogens11050551