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Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection

Sokhela et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac266, COVER, NCT04561063
Aug 2022  
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Mortality 66% Improvement Relative Risk Hospitalization 79% Symp. case 17% Case -21% primary Nitazoxanide  COVER  Prophylaxis  RCT Is prophylaxis with nitazoxanide beneficial for COVID-19? RCT 505 patients in South Africa (December 2020 - January 2022) Lower hospitalization (p=0.5) and fewer symptomatic cases (p=0.49), not sig. c19early.org Sokhela et al., J. Antimicrobial Chemo.., Aug 2022 Favorsnitazoxanide Favorscontrol 0 0.5 1 1.5 2+
Prophylaxis RCT 828 high-risk participants in South Africa, showing no significant difference with nitazoxanide and sofosbuvir/daclatasvir treatment. FLU-PRO results were available for 74% of the nitazoxanide arm compared to 54% of the control arm.
risk of death, 65.6% lower, RR 0.34, p = 1.00, treatment 0 of 240 (0.0%), control 1 of 265 (0.4%), NNT 265, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 79.2% lower, RR 0.21, p = 0.50, treatment 0 of 240 (0.0%), control 2 of 265 (0.8%), NNT 132, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of symptomatic case, 17.0% lower, RR 0.83, p = 0.49, treatment 23 of 240 (9.6%), control 37 of 265 (14.0%), incidence rate ratio .
risk of case, 21.0% higher, RR 1.21, p = 0.67, treatment 23 of 240 (9.6%), control 37 of 265 (14.0%), incidence rate ratio , primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sokhela et al., 12 Aug 2022, Randomized Controlled Trial, South Africa, peer-reviewed, median age 24.0, 11 authors, study period December 2020 - January 2022, trial NCT04561063 (history) (COVER). Contact: ssokhela@ezintsha.org.
This PaperNitazoxanideAll
Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection
Simiso Sokhela, Bronwyn Bosch, Andrew Hill, Bryony Simmons, Joana Woods, Hilary Johnstone, Godspower Akpomiemie, Leah Ellis, Andrew Owen, Carmen Perez Casas, Willem Daniel Francois Venter
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac266
Background: The COVER trial evaluated whether nitazoxanide or sofosbuvir/daclatasvir could lower the risk of SARS-CoV-2 infection. Nitazoxanide was selected given its favourable pharmacokinetics and in vitro antiviral effects against SARS-CoV-2. Sofosbuvir/daclatasvir had shown favourable results in early clinical trials. Methods: In this clinical trial in Johannesburg, South Africa, healthcare workers and others at high risk of infection were randomized to 24 weeks of either nitazoxanide or sofosbuvir/daclatasvir as prevention, or standard prevention advice only. Participants were evaluated every 4 weeks for COVID-19 symptoms and had antibody and PCR testing. The primary endpoint was positive SARS-CoV-2 PCR and/or serology ≥7 days after randomization, regardless of symptoms. A Poisson regression model was used to estimate the incidence rate ratios of confirmed SARS-CoV-2 between each experimental arm and control.
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{ 'key': '2022081203470166300_dkac266-B29', 'doi-asserted-by': 'crossref', 'first-page': '1', 'DOI': '10.1186/s12879-015-1330-0', 'article-title': 'Development of the Flu-PRO: a patient-reported outcome (PRO) instrument ' 'to evaluate symptoms of influenza', 'volume': '16', 'author': 'Powers', 'year': '2016', 'journal-title': 'BMC Infect Dis'}, { 'key': '2022081203470166300_dkac266-B30', 'doi-asserted-by': 'crossref', 'first-page': '509', 'DOI': '10.1136/postgradmedj-2021-140287', 'article-title': 'Sofosbuvir with daclatasvir and the outcomes of patients with COVID-19: ' 'a systematic review and meta-analysis with GRADE assessment', 'volume': '98', 'author': 'Zein', 'year': '2022', 'journal-title': 'Postgrad Med J'}, { 'key': '2022081203470166300_dkac266-B31', 'doi-asserted-by': 'crossref', 'first-page': '5771', 'DOI': '10.1038/s41598-022-09741-5', 'article-title': 'Efficacy and safety of the sofosbuvir/velpatasvir combination for the ' 'treatment of patients with early mild to 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the intensity of COVID-19 ' 'outbreaks among health personnel', 'volume': '3', 'author': 'Mendieta Zerón', 'year': '2021', 'journal-title': 'World Acad Sci J'}, { 'key': '2022081203470166300_dkac266-B35', 'article-title': 'Efficacy and safety of nitazoxanide combined with ritonavir-boosted ' 'atazanavir for the treatment of mild to moderate COVID-19', 'author': 'Fowotade', 'year': '2022', 'journal-title': 'medRxiv'}, { 'key': '2022081203470166300_dkac266-B36', 'doi-asserted-by': 'crossref', 'first-page': '585', 'DOI': '10.1002/cpt.2463', 'article-title': 'An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide ' 'in healthy volunteers: an antiviral candidate for SARS-CoV-2', 'volume': '111', 'author': 'Walker', 'year': '2021', 'journal-title': 'Clin Pharmacol Ther'}, {'key': '2022081203470166300_dkac266-B37', 'author': 'Schmidt'}, { 'key': '2022081203470166300_dkac266-B38', 'doi-asserted-by': 'crossref', 'first-page': '2355', 'DOI': '10.1080/21645515.2018.1460987', 'article-title': 'Vaccine hesitancy – a potential threat to the achievements of ' 'vaccination programmes in Africa', 'volume': '14', 'author': 'Cooper', 'year': '2018', 'journal-title': 'Hum Vaccin Immunother'}, { 'key': '2022081203470166300_dkac266-B39', 'doi-asserted-by': 'crossref', 'first-page': '921', 'DOI': '10.1080/14760584.2021.1949291', 'article-title': 'COVID-19 vaccine hesitancy in South Africa: how can we maximize uptake ' 'of COVID-19 vaccines?', 'volume': '20', 'author': 'Cooper', 'year': '2021', 'journal-title': 'Expert Rev Vaccines'}, {'key': '2022081203470166300_dkac266-B40', 'author': 'BBC News'}, {'key': '2022081203470166300_dkac266-B41', 'author': 'Ritchie', 'year': '2022'}, {'key': '2022081203470166300_dkac266-B42', 'author': 'WHO', 'year': '2021'}, {'key': '2022081203470166300_dkac266-B43', 'author': 'ClinicalTrials.gov', 'year': '2022'}], 'container-title': 'Journal of Antimicrobial Chemotherapy', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/jac/advance-article-pdf/doi/10.1093/jac/dkac266/45349402/dkac266.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/jac/advance-article-pdf/doi/10.1093/jac/dkac266/45349402/dkac266.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 8, 12]], 'date-time': '2022-08-12T03:49:38Z', 'timestamp': 1660276178000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkac266/6661458'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 8, 12]]}, 'references-count': 43, 'URL': 'http://dx.doi.org/10.1093/jac/dkac266', 'relation': {}, 'ISSN': ['0305-7453', '1460-2091'], 'subject': ['Infectious Diseases', 'Pharmacology (medical)', 'Pharmacology', 'Microbiology (medical)'], 'published': {'date-parts': [[2022, 8, 12]]}}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment 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.
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