NCT05305508

Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

A Randomized, Placebo-controlled, Double-blind, Monocenter, Phase II Trial to Assess the Efficacy of Calcium Dobesilate (CaD) vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Hervé SPECHBACH · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of CaD in reducing SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, documented with a positive SARS-CoV-2 PCR and with the occurrence of COVID-19 symptoms.

Detailed description

This study is a phase II, randomized, double-blind, placebo-controlled, monocenter trial. The study will assess the efficacy and safety of CaD compared to placebo in reducing SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, as well as monitoring symptoms severity, progression of the disease to severe form, and persistence of symptoms. The treatment period is seven consecutive days, followed by a 12-weeks observational period without treatment administration. Enrolled patients will be randomized, in a ratio of 1:1 into the following treatment groups: - IMP arm: patients will receive 2 x 2 capsules of Calcium Dobesilate (CaD) 500 mg (total of 2000 mg) daily for seven consecutive days \- Placebo arm: patients will receive 2 x 2 capsules of matching placebo (Mannitol 500 mg) daily for seven consecutive days.

Conditions

• COVID-19 Virus Disease

Interventions

Type	Name	Description
DRUG	Calcium Dobesilate	The treatment (CaD, Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.
DRUG	Mannitol	The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.

Timeline

• Start date: 2022-05-17
• Primary completion: 2023-11-10
• Completion: 2024-02-05
• First posted: 2022-03-31
• Last updated: 2024-02-28

Locations

1 site across 1 country: Switzerland