Ivermectin as adjuvant to hydroxychloroquine in patients resistant to standard treatment for SARS-CoV-2: results of an open-label randomized clinical study
Kishoria et al.,
Ivermectin as adjuvant to hydroxychloroquine in patients resistant to standard treatment for SARS-CoV-2:..,
Paripex - Indian Journal of Research, doi:10.36106/paripex/4801859
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.
This study is excluded in the after exclusion results of meta
analysis:
excessive unadjusted differences between groups.
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.
Abstract: PARIPEX - INDIAN JOURNAL OF RESEARCH | Volume - 9 | Issue - 8 | August - 2020 | PRINT ISSN No. 2250 - 1991 | DOI : 10.36106/paripex
ORIGINAL RESEARCH PAPER
Medicine
IVERMECTIN AS ADJUVANT TO
HYDROXYCHOLOROQUINE IN PATIENTS RESISTANT
TO STANDARD TREATMENT FOR SARS-CoV-2:
KEY WORDS:
RESULTS OF AN OPEN-LABEL RANDOMIZED
CLINICAL STUDY
Dr. Naveen
Kishoria*
Dr. S.L Mathur
Dr.Veeram
Parmar
Dr. Rimple Jeet
Kaur
Dr. Harish
Agarwal
Dr. B.S Parihar
Department of Medicine, Dr. S. N. Medical College, Jodhpur*Corresponding
Author
Dr Somil Verma
Department of Medicine, Dr. S. N. Medical College, Jodhpur
Department of Medicine, Dr. S. N. Medical College, Jodhpur
Department of Medicine, Dr. S. N. Medical College, Jodhpur
Department of Pharmacology, Dr. S. N. Medical College, Jodhpur
Department of Medicine, Dr. S. N. Medical College, Jodhpur
Department of Medicine, Dr. S. N. Medical College, Jodhpur
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
pneumonia in humans.1
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
27th, June 2020.2
The clinical manifestations of COVID-19 range from fever,
cough, fatigue, sore throat, shortness of breath and less
common symptoms such as headache, nausea and diarrhea.3,4
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
admission.5,6The most common complications are sepsis,
respiratory failure, acute respiratory distress syndrome
(ARDS), cardiac injury and acute kidney injury.
As per WHO the mild COVID-19 illness may include:
uncomplicated upper respiratory tract viral infection
symptoms such as fever, fatigue, cough (with or without
sputum production), anorexia, malaise, muscle pain, sore
throat, dyspnea, nasal congestion, or headache. Rarely,
patients may also present with diarrhoea, nausea, and
vomiting.7
According to a recent Chinese study, about 80% of patients
present with mild disease and the overall case-fatality rate is
about 2.3% but reaches 8.0% in patients aged 70 to 79 years
and 14.8% in those aged ≥80 years.7 However, there is
probably an important number of asymptomatic carriers in
the population, and thus the mortality rate is probably
overestimated. India is facing the COVID-19 wave with more
than 145,380 cases, as of May 2020. Thus, there is an urgent
50
need for an effective treatment to treat asymptomatic patients
and to decrease the duration of virus carriage in order to limit
the transmission in the community. Among candidate drugs to
treat COVID-19, repositioning of old drugs for use as antiviral
treatment is an interesting strategy because knowledge on
safety profile, side effects, posology and drug..
Late treatment
is less effective
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit