A study to evaluate the effect and safety of a phytopharmaceutical drug in treatment of Coronavirus infection

Phase 2

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/05/025397
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

This is an open label, randomized, comparative, multi-centre, parallel group, controlled clinical study. This study is being conducted across multiple centers in India.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-06
• Study Completion: 2020-08-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Subjects will be included in the study if they meet all of the following criteria: 1.
• Patient who provides written informed consent 2.
• Male or non-pregnant, non-lactating female patient aged ≥ 18 and ≤ 75 years (both inclusive) 3.
• Patients with body temperature > 37.3℃ with cough/ shortness of breath 4.
• Patient with moderate COVID-19 infection having either one of the following criteria a.
• PaO2/ FiO2: 200-300 OR b.
• Respiratory Rate > 24/min and SaO2/ SpO2 ≤ 93% on room air 5.
• Patient with RT-PCR confirmed diagnosis of COVID-19 6.
• Patient who is able to take the drug orally and comply with study procedures 7.
• Women of childbearing potential must have a negative urine pregnancy test prior to study entry.

Exclusion Criteria

• Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: 1.
• Patient with persistent vomiting 2.
• Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections 3.
• Patient with altered mental state 4.
• Patient with multiple organ failure requiring ICU monitoring and the treatment 5.
• Patient with respiratory failure and requiring ventilation 6.
• Patient with history of retinopathy or macular degeneration 7.
• Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency 8.
• Patient with prolonged QTc-interval at baseline ECG (>450 ms in males or > 470 ms in females) 9.
• Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration 10.
• Patient with history of evidence of chronic interstitial infiltration at imaging 12.
• Patient with history of hospitalization within the past six months for respiratory failure 13.
• Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., heart failure, COPD, hypertension, liver disease, chronic respiratory failure, chronic kidney disease, diabetes, anaemia etc.) that, in the opinion of the Investigator precludes the subject’s participation in the study or interferes with the interpretation of the study results.
• Patient with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
• Patient who has received specific antiviral drugs ritonavir/ lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week prior to admission 16.
• Investigators, study personnel, sponsor’s representatives and their first degree relatives.
• Note: Persistent vomiting is more than three episodes of vomiting in 12 hours, preventing adequate oral hydration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients showing clinical improvement	Day 14
Clinical improvement defined as patient meeting discharge criteria OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale.	Day 14
Hospital Discharge Criteria is defined as resolution of symptoms, radiological improvement with a documented virological clearance in 2 samples at least 24 hours apart.	Day 14

Secondary Outcome Measures

Name	Time	Method
Time (Days) to clinical improvement	upto 28 days
Proportion of patients showing clinical improvement	Day 7 and Day 28
Time to normalization of fever without use of antipyretics in last 24 hours	upto 28 days
Time to alleviation of cough	upto 28 days
Time to first negative SARS-CoV-2 RT-PCR in in upper or lower respiratory tract specimen	upto 28 days
Duration (days) of supplemental oxygen therapy	upto 28 days
Proportion of patients showing deterioration of clinical condition as assessed by at least 1 point worsening on 7 point ordinal scale (non-invasive ventilation, mechanical ventilation, ECMO or death)	upto 28 days
Duration (days) of hospitalization	upto 28 days
Number of deaths (All cause mortality)	upto Day 28
Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)	upto 28 days

Trial Locations

Locations (11)

All India institute of medical science; 🇮🇳 Raipur, CHHATTISGARH, India

Apex Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

B.J. Medical College and Civil hospital,; 🇮🇳 Ahmadabad, GUJARAT, India

Bharati Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Chirayu Medical College and Hospital; 🇮🇳 Bhopal, MADHYA PRADESH, India

Padmashree Dr D Y Patil Medical College Hospital & Research Center; 🇮🇳 Mumbai, MAHARASHTRA, India

Sri Ramachandra Institute of Higher Education and Research (DU) Clinical Research Division; 🇮🇳 Chennai, TAMIL NADU, India

St. George’s Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

T.N. Medical College & B.Y.L. Nair Ch. Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Victoria Hospital, Bangalore Medical College and Research Institute; 🇮🇳 Bangalore, KARNATAKA, India

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All India institute of medical science

🇮🇳Raipur, CHHATTISGARH, India

Dr Md Sabah Siddiqui

Principal investigator

8518881911

dr.sabahsiddiqui@gmail.com