COVID-19 disease MedDRA version: 23.0 Level: LLT Classification code 10070267 Term: SARS virus test positive System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Granudoxy 100mg
Product Name: Granudoxy
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
CHU Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient who has signed informed consent - Man or woman over 45 years of age. - Patient with SARS-CoV-2 positive PCR (sample less than 48h old) - Symptomatic patient, having at least one of the following symptoms without hospitalisation criteria : General symptoms: fever, headache, asthenia ENT symptoms: sore throat, rhinorrhea Respiratory symptoms: dyspnoea, breathing rate > 22/min, Digestive symptoms: nausea, vomiting, diarrhoea - Patient with at least one of the following risk factors for adverse events: = 70 years of age, BMI > 30, cardiovascular history (stroke, coronary artery disease, complicated hypertension, cardiac surgery, NYHA III or IV heart failure), respiratory pathology likely to decompensate with viral infection, respiratory failure, poorly controlled and/or complicated diabetes, patients with chronic renal failure on dialysis, cancer patients under treatment - Patient with social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: - Lactose intolerant patient -Patient requiring immediate hospitalisation for any medical reason - Patient with more than 5 days of clinical signs at inclusion visit - Patient asymptomatic or with isolated anosmia - Patient with history of doxycycline or tetracycline allergy or one of the excipients of the speciality GRANUDOXY 100 mg tablet - Patient with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases) due to the presence of lactose in the experimental treatment. - Patient with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) due to the presence of sucrose in the experimental treatment. - Pregnant or breastfeeding woman - Patient participating in another clinical trial - Patient having a photosensitive skin pathology - Patient treated with oral anticoagulant - Patient treated with oral retinoids: isotretinoin, alitretinoin, acitretinoin - Patient treated with vitamin A - Patient treated with systemic antibiotic for the duration of treatment - Patient treated with barbiturates, carbamazepine or phenytoin or fosphenytoin - Patient with treatment that may affect CoV2-SARS infection: chloroquine, hydroxychloroquine, remdesivir, ganciclovir, acyclovir, ribavirin, lopinavir/ritonavir. - Patient under guardianship or trusteeship or in safeguard of justice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Criteria corresponding to the main objective o Percentage of patients hospitalized for COVID-19 after at least 48 hours of experimental treatment - Criterion corresponding to the second main objective nested : o Percentage of patients requiring mechanical ventilatory assistance ;Timepoint(s) of evaluation of this end point: Day 28;Main Objective: Decrease the percentage of patients requiring hospitalization for COVID-19 infection, after at least 48 hours of treatment. Decrease the percentage of patients requiring mechanical ventilatory support.;Secondary Objective: - Decrease the percentage of patients with positive PCR SARS-CoV-2 at D7 (+/- 2 days) after the start of experimental treatment. - Decrease the total length of hospital stay - Decrease the length of hospitalization in intensive care or intensive care unit - Decrease the duration of mechanical ventilatory assistance - Decrease the number of deaths related to SARS-CoV-2 infection - Assessing the safety / tolerance of doxycycline - Identifying the characteristics of doxycycline-responsive patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of positive SARS-CoV-2 PCR tests at D-1/D0 and D7 (+/- 2 days) - Total length of hospital stay - Total length of hospital stay in intensive care or intensive care unit - Duration of mechanical ventilatory assistance - Number of deaths related to SARS-CoV-2 infection - Number of EI/EIG in both arms - Characteristics of doxycycline responders: sex, age, number and type of severity criteria, serology. ;Timepoint(s) of evaluation of this end point: Day 28 | — |
Countries
France
Contacts
Public ContactDirection Recherche Innovation
CHU Nantes
Outcome results
None listed