Small RCT of hospitalized patients in India with 19 ivermectin patients and 13 control patients, with all receiving SOC including HCQ, showing no significant differences. The patient population is biased because the study recruited patients that did not respond to standard treatment.
Authors do not specify the treatment delay but it is likely relatively late because the patients had already undergone standard treatment. Criteria for discharge are not provided. The time of discharge status is not specified and may not have been an equal time since treatment initiation for all patients.
Authors indicate 19 treatment and 16 control patients, but the results only show 13 control patients. Authors do not indicate why the other 3 are missing.
Randomization in this small sample resulted in very large differences in the groups, with over twice as many in the ivermectin group with age >40, and the only 2 patients with age >60 both in the ivermectin group. Authors did not adjust for these differences.
Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture.
Porter show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.
This study is excluded in the after exclusion results of meta
analysis:
excessive unadjusted differences between groups.
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risk of no hospital discharge, 7.5% higher, RR 1.08, p = 1.00, treatment 11 of 19 (57.9%), control 7 of 13 (53.8%).
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risk of no viral clearance, 7.5% higher, RR 1.08, p = 1.00, treatment 11 of 19 (57.9%), control 7 of 13 (53.8%), day 3, primary outcome.
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risk of no viral clearance, 220.0% higher, RR 3.20, p = 0.45, treatment 1 of 5 (20.0%), control 0 of 6 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 5.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Kishoria et al., 31 Aug 2020, Randomized Controlled Trial, India, peer-reviewed, 7 authors, dosage 12mg single dose.
PARIPEX INDIAN JOURNAL OF RESEARCH
Dr Naveen Kishoria, Dr S L Mathur, Dr Veeram Parmar, Dr Rimple Jeet Kaur, Dr Harish Agarwal, Dr B S Parihar, Dr Somil Verma
doi:10.36106/paripex
BACKGROUND: A cluster of pneumonia cases of unknown etiology was reported from the city of Wuhan, in the Hubei province of China, in December 2019. A novel coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the causative agent of the disease which was subsequently termed as the coronavirus disease (COVID-19) by the World Health Organization (WHO). SARS-CoV-2 mainly affects the lower respiratory tract and manifests as 1 pneumonia in humans. The incidence of COVID-19 continues to rise, with 9,653,048 laboratory-confirmed cases and 491,128 deaths worldwide and India has reported 508,953 cases and 15,685 deaths till th 2 27 , June 2020. The clinical manifestations of COVID-19 range from fever, cough, fatigue, sore throat, shortness of breath and less 3,4 common symptoms such as headache, nausea and diarrhea. The most common abnormalities in vital signs are increased temperature and tachypnea. The most common radiological findings are bilateral pulmonary infiltrates, ground glass opacities and consolidation. The most common findings associated with severe disease are older age, d-dimer levels greater, higher SOFA score, elevated IL-6, increased Lactate Dehydrogenase, hyperferritinemia and lymphopenia on 5,6 admission. The most common complications are sepsis, respiratory failure, acute respiratory distress syndrome (ARDS), cardiac injury and acute kidney injury.
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