Targeting TGF-β pathway with COVID-19 Drug Candidate ARTIVeda/PulmoHeal Accelerates Recovery from Mild-Moderate COVID-19
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Abstract
Our COVID-19 drug candidate ARTIVeda™/PulmoHeal is a novel gelatin capsule formulation of the Artemisia extract Ayurveda for oral delivery of TGF-β targeting anti-malaria phytomedicine Artemisinin with documented anti-inflammatory and anti-SARS-CoV-2 activity. Here we report the safety and efficacy of ARTIVeda™ in adult COVID-19 patients with symptomatic mild-moderate COVID-19, who were treated in a randomized, open-label Phase IV study in Bangalore, Karnataka, India (Clinical Trials Registry India identifier: CTRI/2020/09/028044). ARTIVeda showed a very favorable safety profile, and the only ARTIVeda-related adverse events were transient mild rash and mild hypertension. Notably, ARTIVeda, when added to the SOC, accelerated the recovery of patients with mild-moderate COVID-19. While all patients were symptomatic at baseline (WHO score = 2-4), 31 of 39 (79.5%) of patients treated with ARTIVeda plus SOC became asymptomatic (WHO score = 1) by the end of the 5-day therapy, including 10 of 10 patients with severe dry cough 7 of 7 patients with severe fever. By comparison, 12 of 21 control patients (57.1%) treated with SOC alone became asymptomatic on day 5 (P=0.028, Fisher’s exact test). This clinical benefit was particularly evident when the treatment outcomes of hospitalized COVID-19 patients (WHO score = 4) treated with SOC alone versus SOC plus ARTIVeda were compared. The median time to becoming asymptomatic was only 5 days for the SOC plus ARTIVeda group (N=18) but 14 days for the SOC alone group (N=10) (P=0.004, Log-rank test). These data provide clinical proof of concept that targeting the TGF-β pathway with ARTIVeda may contribute to a faster recovery of patients with mild-moderate COVID-19 when administered early in the course of their disease.
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SciScore for 10.1101/2021.01.24.21250418: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Patients willing to give their informed consent to participate in the clinical trial.
IRB: The study was approved by Ethics Committees at the three participating institutions: 1) Government Medical College & Government General Hospital, Srikakulam, ANDHRA PRADESH. 2) Rajarshi Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital, MAHARASHTRARandomization ARTI-19 Clinical Study: The ARTI-19 is a randomized, open-label Phase IV study was designed to evaluate the safety and efficacy of ARTIVeda when used in combination with the standard of care (SOC) in mild-moderate COVID-19 patients in Bangalore, Karnataka, India. Blind… SciScore for 10.1101/2021.01.24.21250418: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Patients willing to give their informed consent to participate in the clinical trial.
IRB: The study was approved by Ethics Committees at the three participating institutions: 1) Government Medical College & Government General Hospital, Srikakulam, ANDHRA PRADESH. 2) Rajarshi Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital, MAHARASHTRARandomization ARTI-19 Clinical Study: The ARTI-19 is a randomized, open-label Phase IV study was designed to evaluate the safety and efficacy of ARTIVeda when used in combination with the standard of care (SOC) in mild-moderate COVID-19 patients in Bangalore, Karnataka, India. Blinding not detected. Power Analysis not detected. Sex as a biological variable Age limit: 21 to 60 years of age male, or non-pregnant or non-lactating female; 3. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04382040 Recruiting A Phase II, Controlled Clinical Study Designed to Evaluate t… NCT04387240 Not yet recruiting Evaluating the Efficacy of Artesunate in Adults With Mild Sy… NCT04502342 Enrolling by invitation Add on to Azythromycine, Phytomedicine and/or Antimalarial D… NCT04475107 Recruiting The Efficacy and Safety of Pyramax in Mild to Moderate COVID… NCT04553705 Recruiting Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed,… NCT04374019 Recruiting Novel Agents for Treatment of High-risk COVID-19 Positive Pa… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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