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

NCT05305508 | Completed Phase 2

• 1 other identifier: 2022-00000
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Virus Disease

Keywords

Calcium Dobesilate; Viral load; COVID-19 symptoms

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 4, defined by Polymerase Chain Reaction (PCR) threshold cycles. PCR reaction happens in cycles of amplification. Inclusion criteria to enter in the study is a RT-PCR positive for SARS-CoV-2, which correspond to 25 cycles (or lower) of the RT-PCR test. The participant will be tested at day 4 after treatment to evaluate if the viral load has decreased. To do that, another RT-PCR SARS-CoV-2 will be performed. A higher value of RT-PCR cycles compared to the one obtained when the participat was diagnosed COVID-19 positive, is considered a reduction from baseline.

  baseline and day 4

Secondary Outcomes (6)

• SARS-CoV-2 Viral Load at day 8

  baseline and day 8

• SARS-CoV-2 Viral Load negativity

  day 4, 8 and 21

• Symptoms

  day 4, 8 and 21

• Symptoms resolution

  day 4, 8 and 21

• Persistent COVID-19 symptoms

  day 84

Study Arms (2)

placebo

PLACEBO COMPARATOR

The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.

Drug: Mannitol

Calcium Dobesilate

EXPERIMENTAL

The CaD (Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.

Drug: Calcium Dobesilate

Interventions

Calcium Dobesilate DRUG

The treatment (CaD, Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.

Also known as: DOXIUM 500, OM Pharma

Calcium Dobesilate

Mannitol DRUG

The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.

Also known as: Placebo

placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hervé SPECHBACH: lead
• OM Pharma SA: collaborator

Study Sites (1)

Division and Department of Primary Care Medicine, Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (20)

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  PMID: 38719313 DERIVED

Related Links

• Compendium.ch
• 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;

MeSH Terms

Conditions

COVID-19

Interventions

Calcium Dobesilate; Mannitol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• Hervé SPECHBACH, MD

  HUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The central pharmacy of the HUG is responsible for preparation of the randomization list and of the blinding of the study treatments. Randomization will be done in variable-sized blocks (size 4) in random sequence. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Associate Assistant Physician at Primary Care Medicine department HUG, Geneva University Hospitals

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: March 31, 2022
• Study Start: May 17, 2022
• Primary Completion: November 10, 2023
• Study Completion: February 5, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CH (1)