Antiviral Combination Clinically Better Than Standard Therapy in Severe but Not in Non-Severe COVID-19
RCT 111 patients in India in 5 groups: severe patients: A) standard treatment, B) hydroxychloroquine+ribavirin+standard treatment, or C) lopinavir+ritonavir+ribavirin+standard treatment, and non-severe: A) standard treatment or B) hydroxychloroquine+ribavirin. Non-severe patients were transferred to the severe group on progression.
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.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Panda et al., 30 Sep 2021, Randomized Controlled Trial, India, peer-reviewed, 13 authors, study period June 2020 - May 2021, this trial uses multiple treatments in the treatment arm (combined with ribavirin) - results of individual treatments may vary, trial
CTRI/2020/06/025575.
Contact:
motherprasanna@rediffmail.com.
Abstract: Clinical Pharmacology: Advances and Applications
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ORIGINAL RESEARCH
Antiviral Combination Clinically Better Than
Standard Therapy in Severe but Not in Non-Severe
COVID-19
Prasan Kumar Panda 1
Budha O Singh 1
Bikram Moirangthem 1
Yogesh Arvind Bahurupi 2
Sarama Saha 3
Girraj Saini 4
Minakshi Dhar 1
Mukesh Bairwa 1
Venkatesh Srinivasa Pai 1
Ankit Agarwal 5
Girish Sindhwani 6
Shailendra Handu 7
Ravi Kant 8
1
Department of Medicine (Infectious
Disease Division), All India Institute of
Medical Sciences (AIIMS), Rishikesh,
India; 2Department of Community and
Family Medicine, All India Institute of
Medical Sciences (AIIMS), Rishikesh,
India; 3Department of Biochemistry, All
India Institute of Medical Sciences
(AIIMS), Rishikesh, India; 4Department of
Nursing, All India Institute of Medical
Sciences (AIIMS), Rishikesh, India;
5
Department of Critical Care Medicine,
All India Institute of Medical Sciences
(AIIMS), Rishikesh, India; 6Department of
Pulmonary Medicine, All India Institute of
Medical Sciences (AIIMS), Rishikesh,
India; 7Department of Pharmacology, All
India Institute of Medical Sciences
(AIIMS), Rishikesh, India; 8Department of
General Surgery, All India Institute of
Medical Sciences (AIIMS), Rishikesh, India
Correspondence: Prasan Kumar Panda
Department of Medicine (Infectious
Disease Division), All India Institute of
Medical Sciences (AIIMS), Sixth Floor,
College Block, Rishikesh, 249203, India
Tel +91 9868999488
Email motherprasanna@rediffmail.com
Purpose: Definitive antiviral treatment is not available for COVID-19 infection, with the
exception of remdesivir, which still evokes many doubts. Various monotherapy or combina
tion therapies with antivirals or other agents have been tried. The present study aims to
evaluate the therapeutic potential of hydroxychloroquine and lopinavir–ritonavir in combina
tion with ribavirin in mild–severe COVID-19.
Patients and Methods: A single-center, open-label, parallel-arm, stratified randomized
controlled trial evaluated the therapeutic potential of combination antiviral therapies.
Enrolled patients in the severe category were randomized into three groups: (A) standard
treatment, (B) hydroxychloroquine+ribavirin+standard treatment, or (C) lopinavir+ritonavir
+ribavirin+standard treatment; while the non-severe category comprised two groups: (A)
standard treatment or (B) hydroxychloroquine+ribavirin. Combination antivirals were 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: In total, 111 patients were randomized: 24, 23, and 24 in severe categories A, B,
and C, respectively, and 20 in each of the non-severe groups. Two patients receiving ribavirin
experienced drug induced liver injury, and another developed QT prolongation after hydro
xychloroquine. 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 72 hours (P>0.05).
Conclusion: Though the results failed to show statistical superiority of the antiviral
combination therapies to that of the standard therapy in both the severe and..
Late treatment
is less effective
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