Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.
NCT ID: NCT05305508
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2022-05-17
2024-02-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Pharmacists will be un-blinded. Care providers and/or outcome assessors, nurses, clinical research associates, investigators and patients will be blinded. Participants will be allocated to either the treatment group (CaD) or placebo group at Day 1 visit through randomization process, and will be dispensed the full treatment regimen on-site, including instructions on intake and explanations of side-effects.
The investigators will receive from the central pharmacy of the HUG all the study treatments and the participant's allocated treatment randomization number. Thus, the subjects who meet the eligibility criteria will dynamically be randomized at 1:1 ratio and be assigned either to the CaD or to the placebo arms during Day 1 visit.
Study Groups
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placebo
The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.
Mannitol
The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.
Calcium Dobesilate
The CaD (Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.
Calcium Dobesilate
The treatment (CaD, Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.
Interventions
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Calcium Dobesilate
The treatment (CaD, Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.
Mannitol
The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
16 Years
ALL
No
Sponsors
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OM Pharma SA
INDUSTRY
Hervé SPECHBACH
OTHER
Responsible Party
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Hervé SPECHBACH
Principal Investigator, Associate Assistant Physician at Primary Care Medicine department HUG, Geneva University Hospitals
Principal Investigators
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Hervé SPECHBACH, MD
Role: PRINCIPAL_INVESTIGATOR
HUG
Locations
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Division and Department of Primary Care Medicine, Geneva University Hospitals
Geneva, , Switzerland
Countries
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References
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Takashita E, Kinoshita N, Yamayoshi S, Sakai-Tagawa Y, Fujisaki S, Ito M, Iwatsuki-Horimoto K, Halfmann P, Watanabe S, Maeda K, Imai M, Mitsuya H, Ohmagari N, Takeda M, Hasegawa H, Kawaoka Y. Efficacy of Antiviral Agents against the SARS-CoV-2 Omicron Subvariant BA.2. N Engl J Med. 2022 Apr 14;386(15):1475-1477. doi: 10.1056/NEJMc2201933. Epub 2022 Mar 9. No abstract available.
Salamun J, Da Silva T, Ustero P, Gosmain Y, Guessous I, Calmy A, Spechbach H. Study protocol for assessment of the efficacy of calcium dobesilate versus placebo on SARS-CoV-2 viral load in outpatients with COVID-19 (CADOVID study): a randomised, placebo-controlled, double-blind, monocentric phase II trial. BMJ Open. 2024 May 8;14(5):e079574. doi: 10.1136/bmjopen-2023-079574.
Related Links
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Boucau J, Marino C, Regan J, Uddin R, Choudhary MC, Flynn JP, et al. Duration of viable virus shedding in SARS-CoV-2 omicron variant infection. MedRxiv Prepr Serv Health Sci. 2 mars 2022;
Other Identifiers
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2022-00000
Identifier Type: -
Identifier Source: org_study_id
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