Status:
COMPLETED
Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.
Lead Sponsor:
Hervé SPECHBACH
Collaborating Sponsors:
OM Pharma SA
Conditions:
COVID-19 Virus Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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-Co...
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 ...
Eligibility Criteria
Inclusion
- Documented COVID-19 diagnosis (SARS-CoV-2 positivity as assessed by PCR) ≤3 days of symptom appearance, with a CT\<25.
- Symptoms related to Day 1 ≤ 5 days.
- Participant presents at least one of the following acute COVID-19 symptoms: nasal congestion or runny nose, sore throat, headache, myalgia, dry/productive cough, fever, chills, abdominal symptoms (nausea, vomiting, diarrhea, abdominal pain), fatigue, chest pain, palpitations, and shortness of breath.
- Participant is aged ≥ 16 years of age.
- Participant has provided an appropriate signed Informed consent.
Exclusion
- Known hypersensitivity or allergy to any of the study products to be administered.
- Participation in any other investigational device or drug study within 30 days preceding study screening visit.
- Treatment with Calcium Dobesilate or related molecules (e.g., ethamsylate) within 30 days preceding screening visit, or current treatment with any other investigational agent(s).
- Breastfeeding, unless If the patient agrees to stop breastfeeding
- Treatment with any investigational, emergency use authorization-approved, or approved drug for COVID-19, such as, but not limited to: monoclonal antibody treatment, direct or indirect antiviral treatment, and others according to local guidelines.
- Any kind of disorder or medical conditions that, in the opinion of the investigators, may be associated with increased risk to the participant, may affect patients' compliance, or may interfere with study assessments or outcomes.
- Inability to follow and comply with study procedures.
- Participant has hospitalization criteria according to local guidelines (Sat \< 95%, RR \>25) at the time of screening or is admitted to hospital prior to randomization
- Participant is, in the opinion of the investigators, likely to deteriorate in the next 24-48h and require hospitalization
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05305508
Start Date
May 17 2022
End Date
February 5 2024
Last Update
February 28 2024
Active Locations (1)
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1
Division and Department of Primary Care Medicine, Geneva University Hospitals
Geneva, Switzerland, 1211