An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19

Strub-Wourgaft et al., ANTICOV, ANTICOV, Mar 2024
Progression 92% improvement lower risk ← → higher risk Hospitalization 94% Recovery 57% Ivermectin  ANTICOV  EARLY TREATMENT RCT Is early treatment with ivermectin + ASAQ beneficial for COVID-19? RCT 999 patients in multiple countries Trial compares with paracetamol, results vs. placebo may differ Improved recovery with ivermectin + ASAQ (p=0.0000049) c19early.org Strub-Wourgaft et al., ANTICOV, March 2024 0 0.5 1 1.5 2+ RR
Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020, now with p < 0.0000000001 from 106 studies, recognized in 24 countries.
Lower risk for mortality, ventilation, ICU, hospitalization, recovery, cases, and viral clearance.
No treatment is 100% effective. Protocols combine treatments.
6,600+ studies for 220+ treatments. c19early.org
Meta-analysis
RCT 1,942 patients testing HCQ, lopinavir/ritonavir, nitazoxanide/ciclesonide, ivermectin/ASAQ, and fluoxetine/budesonide compared wirth paracetamol.
Paracetamol was used as a control group. Results with concurrent controls are only provided for nitazoxanide/ciclesonide. Other groups only have comparisons with the full control group. The full control group continues beyond the time of most arms, including patients at later times when COVID-19 risk was lower, therefore results may underestimate efficacy.
The nitazoxanide/ciclesonide concurrent controls are closer in time than the full group for ivermectin/ASAQ and fluoxetine/budesonide and may be a more appropriate comparison. The control group in this case shows worse results. We currently use the full control group results to be conservative.
Authors indicate that the data is available however it is not available as of May 2026.
This study is excluded in the after exclusion results of meta-analysis: significant confounding by time possible.
Important missing comments or errors? Let us know.
Study covers ivermectin, artemisinin, HCQ, budesonide, and lopinavir/ritonavir.
risk of progression, 91.7% lower, RR 0.08, p = 0.38, treatment 0 of 182 (0.0%), control 9 of 817 (1.1%), NNT 91, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), SpO2 ≤93 or death, day 21, Table 14.2.2.1.
risk of hospitalization, 93.6% lower, RR 0.06, p = 0.14, treatment 0 of 182 (0.0%), control 12 of 817 (1.5%), NNT 68, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), COVID-19 hospitalization, day 21, Table 14.2.2.13.
risk of no recovery, 56.5% lower, OR 0.43, p < 0.001, treatment 182, control 817, inverted to make OR<1 favor treatment, disease free, day 21, Table 14.2.2.13, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Strub-Wourgaft et al., 28 Mar 2024, Randomized Controlled Trial, multiple countries, preprint, 12 authors, average treatment delay 3.0 days, this trial compares with another treatment - results may be better when compared to placebo, this trial uses multiple treatments in the treatment arm (combined with ASAQ) - results of individual treatments may vary, ANTICOV trial.
Abstract: DNDi-01-COV (ANTICOV study) Abbreviated Clinical Study Report - Version 1.0 Date: 28 Mar 2024 Abbreviated Clinical Study Report An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19 Short Title Name of product(s) Indication Phase Study Design Consortium Coordinator Consortium Coordinator’s Responsible Medical Officer Sponsors in each country with at least one participant screened Study Initiation Study completion Study Report Date ANTICOV Hydroxychloroquine sulphate; lopinavir/ritonavir ; nitazoxanide/ciclesonide; ivermectin/artesunateamodiaquine; fluoxetine/budesonide; paracetamol Mild/moderate infection in outpatients with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Phase III Multicentre, multiple-country, randomised, open-label, adaptive, platform clinical study in adult patients with confirmed coronavirus disease 2019 (COVID-19) diagnosis and presenting with viral syndrome DNDi, 15 chemin Camille-Vidart, 1202 Geneva, Switzerland (until 01 March 2021: 15 chemin Louis-Dunant, 1202 Geneva, Switzerland) Phone: +41 22 906 9230 Dr Nathalie Strub-Wourgaft Burkina Faso, Guinea: Inserm/ANRS (France) Democratic Republic of the Congo, Kenya, and Sudan: DNDi (Switzerland) Ethiopia: Institute of Tropical Medicine (Belgium) Ghana: Bernhard-Nocht-Institut für Tropenmedizin (Germany) Ivory Coast: Centre Suisse de Recherches Scientifiques (Ivory Coast) Mali: Centre for Vaccine Development (Mali) Mozambique: ISGlobal (Spain) Tanzania: Ifakara Health Institute (Tanzania) Brazil: Cardresearch (Sponsor of Together Trial, Brazil) Date 21 September 2020 21 December 2022 28 March 2024 This study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents CSR Template_Version 1.0_ 11 Apr 2008 – Updated 26 Aug 2020 Page 1 of 1569 1570 DNDi-01-COV (ANTICOV study) Abbreviated Clinical Study Report - Version 1.0 Date: 28 Mar 2024 2. SYNOPSIS Name of Coordinating Sponsor: Drugs for Neglected Diseases initiative (DNDi) Name of Active Ingredients: Hydroxychloroquine sulphate; lopinavir/ritonavir; nitazoxanide/ciclesonide; ivermectin/artesunate-amodiaquine; fluoxetine/budesonide; paracetamol (control) Name of Finished Products: Marketed formulations of the investigational products Title of Study: An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19 Investigators: 12 Coordinating Principal Investigators in 12 countries Study Centre(s): 26 sites (with screened patients) in 12 countries: 11 African countries (Burkina Faso, Democratic Republic of the Congo [DRC], Ethiopia, Ghana, Guinea, Ivory Coast, Kenya, Mali, Mozambique, Sudan, and Tanzania) + Brazil Publication (Reference): None Studied Period (years): First Patient First Visit: 21 Sep 2020 Last Patient Last Visit: 21 Dec 2022 Phase of Development: Phase III Objectives: The overall objective was to determine the efficacy and safety of various treatment regimens in outpatients with mild/moderate coronavirus disease 2019 (COVID-19) to prevent the need for hospitalisation for specialised care due to severe progression of the disease. Primary Objective: • To compare the efficacy of alternative treatment strategies versus (vs) control on the risk of progression..
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ 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. IMA and WCH provide treatment protocols.
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