Clinical trial NCT05305508: Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19 Virus Disease
Keywords: Calcium Dobesilate
Viral load
COVID-19 symptoms
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: OM Pharma SA
First posted: 2022-03-31
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-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.

Eligibility criteria: Inclusion Criteria:

1. Documented COVID-19 diagnosis (SARS-CoV-2 positivity as assessed by PCR) ≤3 days of symptom appearance, with a CT\<25.
2. Symptoms related to Day 1 ≤ 5 days.
3. 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.
4. Participant is aged ≥ 16 years of age.
5. Participant has provided an appropriate signed Informed consent.

Exclusion Criteria:

1. Known hypersensitivity or allergy to any of the study products to be administered.
2. Participation in any other investigational device or drug study within 30 days preceding study screening visit.
3. 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).
4. Breastfeeding, unless If the patient agrees to stop breastfeeding
5. 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.
6. 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.
7. Inability to follow and comply with study procedures.
8. 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
9. Participant is, in the opinion of the investigators, likely to deteriorate in the next 24-48h and require hospitalization

Primary outcomes:
measure: Primary Outcome
timeFrame: baseline and day 4
Secondary outcomes:
measure: SARS-CoV-2 Viral Load at day 8
timeFrame: baseline and day 8
measure: SARS-CoV-2 Viral Load negativity
timeFrame: day 4, 8 and 21
measure: Symptoms
timeFrame: day 4, 8 and 21
measure: Symptoms resolution
timeFrame: day 4, 8 and 21
measure: Persistent COVID-19 symptoms
timeFrame: day 84
measure: Mental and physical score
timeFrame: baseline and 84
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Division and Department of Primary Care Medicine, Geneva University Hospitals
Study officials:
affiliation: HUG
name: Hervé SPECHBACH, MD
role: PRINCIPAL_INVESTIGATOR
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