By: IPP Bureau
Last updated : August 14, 2021 3:11 pm
This therapy may provide the first potential oral treatment for COVID-19, recognizing the global emergency of new SARS-CoV-2 variants
Novatek Pharmaceuticals, INC announced that the company has received FDA approval for its investigational new drug (IND) study; Phase 2 clinical trial for its oral drug, TQ Formula, against Novel Coronavirus 2019 (COVID-19) in the outpatient setting. The study is currently enrolling patients, with 16 out of 60 patients already randomized with no reported serious adverse events (SAEs) reported, to-date.
This is a randomized, double-blind, placebo-controlled phase II study where participants will be randomized 1:1 and will receive up to 14 days of oral dosing.
This therapy may provide the first potential oral treatment for COVID-19 different variants, recognizing the global emergency of new SARS-CoV-2 variants, Novatek Pharmaceuticals, Inc. has commenced the development of additional pre-clinical experiments against new COVID-19 variants as it is very critical to have access to therapeutic options now and beyond the pandemic.
About TQ Formula
TQ Formula is an oral GMP-manufactured drug, which represents a concentrated enteric-coated formulation of Nigella Sativa oil, with a higher than average thymoquinone concentration.
In Vitro, Viral Studies indicate that TQ Formula blocks the viral entry of SARS-CoV-2 (Covid-19) variants through inhibiting angiotensin-converting enzyme 2 (ACE-2).
About the phase 2 study
This is a randomized (1:1), double-blind, placebo-controlled phase 2 study to assess safety and efficacy of the oral drug, TQ Formula (3 g daily dose of enteric-coated 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 the 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. The primary endpoints of the study are Study Population: Up to 60 participants will be randomized 1:1 to receive either TQ Formula Capsules + Standard of Care (SOC) or placebo +SOC. Approximately 2-4 centres in the United States and TQ Formula (Nigella Sativa) 500 mg, 3 capsules, BID, taken orally.