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

Primary Purpose

COVID-19 Virus Disease

Status

Not yet recruiting

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Calcium Dobesilate

Mannitol

About this trial

This is an interventional treatment trial for COVID-19 Virus Disease focused on measuring Calcium Dobesilate, Viral load, COVID-19 symptoms

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Division and Department of Primary Care Medicine, Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

Calcium Dobesilate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

SARS-CoV-2 Viral Load at day 8

Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 8.

SARS-CoV-2 Viral Load negativity

Proportion of patients with viral load negativity or very low viral load (defined by PCR threshold cycles >32) at days 4, 8 and 21.

Symptoms

Time to acute symptom resolution after randomisation to treatment. Proportion of participants with acute symptom resolution at days 4, 8, 21.

Symptoms resolution

Proportion of participants with acute symptom resolution at days 4, 8, 21.

Persistent COVID-19 symptoms

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).

Mental and physical score

SF12 score at day 21 and day 84 (week 12) compared to day 1 (baseline).

Full Information

NCT ID

NCT05305508

First Posted

March 25, 2022

Last Updated

March 31, 2022

Sponsor

Hervé SPECHBACH

Collaborators

OM Pharma SA

1. Study Identification

Unique Protocol Identification Number

NCT05305508

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2022 (Anticipated)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hervé SPECHBACH

Collaborators

OM Pharma SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Virus Disease

Keywords

Calcium Dobesilate, Viral load, COVID-19 symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Calcium Dobesilate

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Calcium Dobesilate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mannitol

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary Outcome

Description

Time Frame

baseline and day 4

Secondary Outcome Measure Information:

Title

SARS-CoV-2 Viral Load at day 8

Description

Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 8.

Time Frame

baseline and day 8

Title

SARS-CoV-2 Viral Load negativity

Description

Proportion of patients with viral load negativity or very low viral load (defined by PCR threshold cycles >32) at days 4, 8 and 21.

Time Frame

day 4, 8 and 21

Title

Symptoms

Description

Time to acute symptom resolution after randomisation to treatment. Proportion of participants with acute symptom resolution at days 4, 8, 21.

Time Frame

day 4, 8 and 21

Title

Symptoms resolution

Description

Proportion of participants with acute symptom resolution at days 4, 8, 21.

Time Frame

day 4, 8 and 21

Title

Persistent COVID-19 symptoms

Description

Time Frame

day 84

Title

Mental and physical score

Description

SF12 score at day 21 and day 84 (week 12) compared to day 1 (baseline).

Time Frame

baseline and 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hervé SPECHBACH, MD

Phone

+41 22 372 95 22

herve.spechbach@hcuge.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Julien Salamun, MD

Phone

+41 22 372 51 06

julien.salamun@hcuge.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hervé SPECHBACH, MD

Organizational Affiliation

HUG

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division and Department of Primary Care Medicine, Geneva University Hospitals

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hervé Spechbach, MD

Phone

+41 22 372 95 22

herve.spechbach@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Julien Salamun, MD

Phone

+41 22 372 51 06

julien.salamun@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Hervé Spechbach, MD

First Name & Middle Initial & Last Name & Degree

Julien Salamun, MD

First Name & Middle Initial & Last Name & Degree

Alexandra Calmy, MD, PhD

First Name & Middle Initial & Last Name & Degree

Idris Guessous, Pr

12. IPD Sharing Statement

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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;

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

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