Publication Ravichandran R, medRxiv, 2021 (preprint)
Funding: Not reported/unclear (The authors acknowledge the generous funding for this study by Mr. Kris Gopalakrishnan, Alumnus, Indian Institute of Technology Madras. He is also the Chairman of Axilor Ventures.)
Conflict of interest: No
Single center / India |
Follow-up duration (days): 14
|Inclusion criteria||Age between 20 and 90 years; RT-PCR Positive; Hospitalised; Normal Kidney Function Test (KFT); Normal Liver Function Test (LFT); Oxygen saturation – 94 or more|
|Exclusion criteria||Hypersensitivity/Allergy to Drugs; Gastritis; Recent heart attack; Severe asthma; Acute kidney injury; Patients on immunosuppressants; Pregnant & lactating mothers; Indomethacin allergy|
75 mg orally once daily for 5 days (BMI<30); twice daily (BMI >30)
Standard care ( / )
Definition of Standard care: Standard care included doxycycline, Ivermectin and Proton Pump Inhibitors. C. Doxycycline 100mg BD, T. Ivermectin 12 mg OD, T. Vitamin C 500mg BD, T. Zinc 50 mg OD, Cough syrup - (Lupituss) 5 ml TDS, T. Pantoprazole 40 mg BD.
210 participants (n1=103 / n2= 107)
|Characteristics of participants|
Mean age : 47
Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0
|In the register|
Reduction in Covid-19 symptoms
|In the report|
Development of hypoxia/desaturation with Sp02 <= 93
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to all available versions of the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study randomized 210 patients of the 300 target sample size specified in the trial registry. This is an interim report. There is no change from the trial registration in the intervention and control treatments. The primary outcome reported in the paper, desaturation and requirement of oxygen, was not pre-specified in the trial registry.
The study was updated on December 17th, 2021 after data from contact with authors.