A Phase 2 interventional study of Calcium Dobesilate and Mannitol in COVID-19 Virus Disease, sponsored by Hervé SPECHBACH. Completed at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Hervé SPECHBACH · Phase 2, Interventional, and Treatment
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.
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 74 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Hervé SPECHBACH as lead sponsor.
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Exclusion Criteria:
The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.
Drug: Mannitol
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.
Also known as: DOXIUM 500, OM Pharma
The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.
Also known as: Placebo
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.
Time frame: baseline and day 4
SARS-CoV-2 Viral Load at day 8
Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 8.
Time frame: baseline and 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.
Time frame: day 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.
Time frame: day 4, 8 and 21
Symptoms resolution
Proportion of participants with acute symptom resolution at days 4, 8, 21.
Time frame: day 4, 8 and 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).
Time frame: day 84
Mental and physical score
SF12 score at day 21 and day 84 (week 12) compared to day 1 (baseline).
Time frame: baseline and 84
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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