Open Label Study to Compare Efficacy, Safety and Tolerability of Hydroxychloroquine Combined With Azithromycin Compared to Hydroxychloroquine Combined With Camostat Mesylate and to "no Treatment" in SARS CoV 2 Virus (COSTA)

Levi et al., NCT04355052, COSTA, NCT04355052, Dec 2020

Estimated 250 patient camostat late treatment RCT with results not reported over 4 years after estimated completion.

5 camostat RCTs have results missing long after expected1-5
The trials report a total of 828 patients, with 4 trials having actual enrollment of 578, and the other estimated.

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Study covers HCQ and camostat.

1. Jeon et al., A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients, NCT04713176, clinicaltrials.gov/study/NCT04713176clinicaltrials.gov.

2. Boutboul et al., A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID), NCT04608266, clinicaltrials.gov/study/NCT04608266clinicaltrials.gov.

3. Keitel-Anselmino et al., Reconvalescent Plasma / Camostat Mesylate Early in Sars-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals, NCT04681430, clinicaltrials.gov/study/NCT04681430clinicaltrials.gov.

4. Palazuelos et al., Randomized, Double-blind, Placebo-controlled, Multicenter, Multi-arm, Phase II Trial of Novel Agents for the Treatment of Mild to Moderate COVID-19 Positive Outpatients, NCT04530617, clinicaltrials.gov/study/NCT04530617clinicaltrials.gov.

5. Levi et al., Open Label Study to Compare Efficacy, Safety and Tolerability of Hydroxychloroquine Combined With Azithromycin Compared to Hydroxychloroquine Combined With Camostat Mesylate and to "no Treatment" in SARS CoV 2 Virus (COSTA), NCT04355052, clinicaltrials.gov/study/NCT04355052clinicaltrials.gov.

Levi et al., 11 Dec 2020, Randomized Controlled Trial, placebo-controlled, trial NCT04355052 (history) (COSTA).

Late treatment
is less effective