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

February 24, 2024 updated by: Hervé SPECHBACH

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Division and Department of Primary Care Medicine, Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
The comparator (placebo, Mannitol 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.
Other Names:
  • Placebo
Experimental: Calcium Dobesilate
The CaD (Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.
Drug: Calcium Dobesilate
The treatment (CaD, Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.
Other Names:
  • DOXIUM 500, OM Pharma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: baseline and day 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 Viral Load at day 8
Time Frame: baseline and day 8
Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 8.
baseline and day 8
SARS-CoV-2 Viral Load negativity
Time Frame: day 4, 8 and 21
Proportion of patients with viral load negativity or very low viral load (defined by PCR threshold cycles >32) at days 4, 8 and 21.
day 4, 8 and 21
Symptoms
Time Frame: day 4, 8 and 21

Time to acute symptom resolution after randomisation to treatment.

Proportion of participants with acute symptom resolution at days 4, 8, 21.
day 4, 8 and 21
Symptoms resolution
Time Frame: day 4, 8 and 21
Proportion of participants with acute symptom resolution at days 4, 8, 21.
day 4, 8 and 21
Persistent COVID-19 symptoms
Time Frame: day 84
Proportion of patients with persistent symptoms (≥1 of the following symptoms: fatigue, headache, intermittent fever, palpitations/tachycardia, sleep disturbance, anxiety, blurred vision, depression, brain fog (difficulty concentrating), loss of memory, dizziness, tinnitus (and other hearing issues), altered smell, altered taste, shortness of breath, chest pain, cough, myalgia (and spasms), neuralgias, arthralgia (joint pain), paraesthesia, nausea, vomiting, diarrhea, constipation, abdominal pain, menstrual and period problems as well as new onset of allergies) at day 84 (week 12).
day 84
Mental and physical score
Time Frame: baseline and 84
SF12 score at day 21 and day 84 (week 12) compared to day 1 (baseline).
baseline and 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hervé SPECHBACH

Collaborators

OM Pharma SA

Investigators

  • Principal Investigator: Hervé SPECHBACH, MD, HUG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

February 5, 2024

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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