Safety and efficacy of antiviral therapy alone or in combination in COVID-19 - a randomized controlled trial (SEV COVID Trial)
Singh et al.,
Safety and efficacy of antiviral therapy alone or in combination in COVID-19 - a randomized controlled trial..,
medRxiv, doi:0.1101/2021.06.06.21258091 (Preprint)
Very small early terminated RCT in India, showing lower mortality but without statistical significance with the very small sample size. Time since symptom onset is not provided. The recovery percentage for non-severe group B (86.7%) does not match any number of recoveries, we have used the closest number (15/17).
risk of death, 47.5% lower, RR 0.53, p = 0.45, treatment 3 of 20 (15.0%), control 6 of 21 (28.6%), NNT 7.4, severe.
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risk of death, 50.0% lower, RR 0.50, p = 0.48, treatment 3 of 37 (8.1%), control 6 of 37 (16.2%), NNT 12, all patients.
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risk of no recovery, 14.1% lower, RR 0.86, p = 0.76, treatment 9 of 20 (45.0%), control 11 of 21 (52.4%), NNT 14, severe.
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risk of no recovery, 8.3% lower, RR 0.92, p = 1.00, treatment 11 of 37 (29.7%), control 12 of 37 (32.4%), NNT 37, all patients.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Singh et al., 8 Jun 2021, Randomized Controlled Trial, India, preprint, 13 authors, this trial uses multiple treatments in the treatment arm (combined with ribavirin) - results of individual treatments may vary.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.06.06.21258091; this version posted June 8, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
Title: Safety and efficacy of antiviral therapy alone or in combination in COVID-19 - a
randomized controlled trial (SEV COVID Trial)
Authors: SEV COVID trial group: Budha O Singh1, Bikram Moirangthem1, Prasan Kumar
Panda1 Yogesh Arvind Bahurupi2, Sarama Saha3, Girraj Saini4, Minakshi Dhar1, Mukesh
Bairwa1, Venkatesh Srinivasa Pai1, Ankit Agarwal5, Girish Sindhwani6, Shailendra Handu7,
Ravikant8
Affiliations: Department of Internal Medicine1, Community and Family Medicine2,
Biochemistry3, Nursing4, Anesthesia and Critical Care Medicne5, Pulmonary Medicine6,
Pharmacology7, and Director8, All India Institute of Medical Sciences (AIIMS), Rishikesh,
Uttarakhand, India
Corresponding Author:
Prasan Kumar Panda
Asst. Professor, Dept. of Internal Medicine,
Sixth Floor, College Block,
All India Institute of Medical Sciences (AIIMS),
Rishikesh, India, 249203
Mob: +91-9868999488
Email: motherprasanna@rediffmail.com
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NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2021.06.06.21258091; this version posted June 8, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
ABSTRACT
Background
Definitive antiviral treatment is not available for COVID-19 infection except remdesivir that
even with many doubts. Various combination antivirals have been tried.
Methods
A single-center, open-label, parallel-arm, stratified randomized controlled trial evaluated the
therapeutic potential of hydroxychloroquine and lopinavir-ritonavir in combination with ribavirin
in COVID-19. Enrolled patients in severe category were randomized into three groups: A:
standard
treatment,
B:
hydroxychloroquine+ribavirin+standard
treatment,
or
C:
lopinavir+ritonavir+ribavirin+standard treatment; while non-severe category into two groups: A:
standard treatment or B: hydroxychloroquine+ribavirin. Combination antivirals was given for 10
days and followed for 28 days. The primary endpoints were safety, symptomatic and laboratory
recovery of organ dysfunctions, and time to SARS-CoV-2 RT-PCR negative report.
Results
Total 111 patients randomized: 24, 23, and 24 in severe category A, B, and C respectively, and
20 in each non-severe group. Two patients receiving ribavirin experienced drug induced liver
injury and another developed QT prolongation after hydroxychloroquine. In the severe category,
47.6%, 55%, and 30.09% in A, B, and C groups respectively showed symptomatic recovery
compared to 93.3% and 86.7% in A and B groups respectively in the non-severe category at
72hrs (P>0.05).
Conclusions
The results failed to show statistical superiority of the antiviral combination therapies to that of
the standard therapy in both the severe and non-severe categories in symptomatic adult patients
of COVID-19. However, results do indicate the benefit of non-standard interventional
combination therapy in severe disease. Furthermore, the dose of..
Late treatment
is less effective
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