COSTA: 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)

Estimated 250 patient camostat late treatment RCT with results not reported over 5 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.

Important missing comments or errors? Let us know.

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

Most accessed treatments

Antiviral effects

Vitamins & Minerals

Host endosomal entry / trafficking

Dual-action mAbs

RdRp

Nasal & Oral Sprays / Rinses

Analgesics

Antiandrogens

Host targets and pathways

Inflammatory and immune modulation

Mpro (Gen 1)

Oxidative stress and cytoprotection

Lifestyles

TMPRSS2

Spike neutralization

Replication inhibition (target unresolved)

COVID-19 mAbs

Pleiotropic modulation

Attachment / entry inhibition

Mpro (Gen 2)

H1RAs

Nutrients and microbiome support

Host mAbs

IL-6 / IL-6R blockade

Physical and extracorporeal interventions

Natural products and extracts

Symptom management

Unconfirmed antiviral rationale

Lifestyle, behaviors, and exposure prevention

Other complication management

Mpro / 3CLpro

Host pyrimidine synthesis

Direct viral inactivation

Endothelial / vascular protection

Direct respiratory tract treatments

Other antibodies, proteins, peptides, cells, and RNA therapies

Secondary infection and coinfection management

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)