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0 0.5 1 1.5 2+ Mortality 48% Improvement Relative Risk Mortality (b) 50% Recovery 14% Recovery (b) 8% HCQ  Singh et al.  LATE TREATMENT  RCT Is late treatment with HCQ + ribavirin beneficial for COVID-19? RCT 74 patients in India (March - October 2020) Lower mortality with HCQ + ribavirin (not stat. sig., p=0.45) Singh et al., medRxiv, June 2021 Favors HCQ Favors control

Safety and efficacy of antiviral therapy alone or in combination in COVID-19 - a randomized controlled trial (SEV COVID Trial)

Singh et al., medRxiv, doi:0.1101/2021.06.06.21258091
Jun 2021  
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HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
*, now known with p < 0.00000000001 from 422 studies, recognized in 42 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,000+ studies for 60+ treatments.
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.
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.
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.
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.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Singh et al., 8 Jun 2021, Randomized Controlled Trial, India, preprint, 13 authors, study period March 2020 - October 2020, this trial uses multiple treatments in the treatment arm (combined with ribavirin) - results of individual treatments may vary.
This PaperHCQAll
Safety and efficacy of antiviral therapy alone or in combination in COVID-19 - a randomized controlled trial (SEV COVID Trial)
Budha O Singh, Bikram Moirangthem, Prasan Kumar Panda, Yogesh Arvind Bahurupi, Sarama Saha, Girraj Saini, Minakshi Dhar, Mukesh Bairwa, Venkatesh Srinivasa Pai, Ankit Agarwal, Girish Sindhwani, Shailendra Handu, Ravikant
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 ribavirin needs to be reconsidered in the Indian population.
Given the results of the findings of the study and availability of a variety of therapeutic approaches including novel antivirals, modifiers of the immune response, or other intrinsic pathways, antiviral combinations may have a role in improving clinical recovery in patients of COVID-19 with severe category whereas only standard therapy is required for non-severe category. Competing interests: The authors declare that they have no competing interests. Trial registration: Funding: Non-funded. Authors' contributions: PKP conceived the trial. PKP, AB, BCS, GC, YAB designed the trial. BCS, BM, SS collected the data. All the authors are part of the trial management committee and were involved in the review, amendments, and approval of the final protocol.
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The, Food and Drug Administration FDA approves first treatment for COVID-19
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Late treatment
is less effective
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