Covid-19 MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Gramplus® 750mg
Product Code: TEE001DP
Pharmaceutical Form: Suppository
INN or Proposed INN: CLOFOCTOL
CAS Number: 37693-01-9
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Institut Pasteur de Lille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Positive SARS-CoV-2 test results within the last 72 hours (obtained using either nasopharyngeal, saliva, or throat samples, by either reverse transcriptase-polymerase chain reaction [RT-PCR] or antigen technic). 2. An onset of any clinical signs and symptoms suggestive of COVID-19 disease (eg, headaches, sore throat, myalgia, fatigue, fever >38°C, nasal congestion, rhinorrhoea, sneezing, cough, anosmia-or-ageusia), with at least one clinical signs and symptoms starting within the last 72 hours. 3. Non-hospitalised patient. 4. Adult male or female patients =50 years of age. 5. Willing to comply with all study procedures. 6. Able to understand and willing to provide informed consent. 7. For females only: At the time of enrolment, negative beta-human chorionic gonadotropin pregnancy test (urine) for women of childbearing potential. 8. Patient covered by health insurance during the study period. 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 288 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 398
Exclusion criteria
Exclusion criteria: 1. Known history of allergic reactions to clofoctol or any of the excipients. 2. Known history of previous severe allergic reactions as anaphylaxis or Stevens-Johnson syndrome whatever the cause. 3. Active and persistent diarrhoea, defined as 3 or more loose or watery stools per day for more than 48 hours. 4. SpO2 =93%. 5. Score of 3 in any individual parameter of the National Early Warning Score, ie: a. Respiratory distress with respiratory rate =25 or =8 breaths/minute; b. Oral body temperature =35°C; c. Systolic blood pressure =90 or =220 mmHg; d. Heart rate =40 or =131 beats/minute. 6. Critically ill patients presenting with 1 of the following: a. Respiratory failure requiring to receive mechanical ventilation; b. Shock. 7. Pregnant or breastfeeding female patients. Women of childbearing potential should have a negative pregnancy test and agree to use a highly effective contraceptive method during the study (eg, oral contraceptive and condom, intra-uterine device and condom, diaphragm with spermicide and condom) and for up to 5 half-lives after the last investigational product (IP) administration. 8. Current participation in another interventional clinical study or participation in another interventional clinical study within 1 month prior to the first dose of IP in this study. 9. Patients having received 1 or more doses of vaccine against SARS-CoV-2. 10. Incarcerated patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of TEE001DP versus placebo on the improvement of patient’s clinical status.;Secondary Objective: Safety: - To assess the safety of TEE001DP versus placebo Virological: - To compare the evolution of viral load between treatment groups. - To assess the impact of initial viral load on treatment efficacy in both treatment groups. Clinical: - To assess the efficacy of TEE001DP versus placebo on the short-term evolution of clinical signs and symptoms of COVID-19 and on the patient’s full recovery. - To compare the use of paracetamol or other standard-of-care treatments for the management of COVID-19 symptoms between treatment groups. Oximetric: - To compare the time to occurrence of oxygen saturation (SpO2) =93% between treatment groups. Other: - To compare patient treatment compliance between treatment groups. - To describe patient treatment acceptability regarding the suppository form in both treatment groups. Exploratory: To compare the evolution of viral load between treatment groups for patients who consented to having a third optional virological test. ;Primary end point(s): The primary endpoint is treatment failure rate in each treatment group, treatment failure being defined at Day 22 as: 1. Occurrence of SpO2 =93% within 10 days after Day 0; and/or 2. Use of home oxygen therapy within 22 days after Day 0; and/or 3. Unscheduled hospitalisation of more than 24 hours related to the infection within 22 days after Day 0.;Timepoint(s) of evaluation of this end point: D22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety Endpoint: 1. Rate of patients who experienced an adverse event (all types/grades) within 22 days after Day 0. Virological Endpoints: 2. Between treatment group difference in the viral load change from Day 0 to Day 3. 3. Relationship between initial viral load and treatment failure rate. Clinical Endpoints: 4. Proportion of patients with 50% decrease in the composite clinical score at Day 10 and the area under the curve of the composite clinical score curve from Day 0 to Day 10. 5. Proportion of patients reaching null composite clinical score from Day 0 to Day 10 in each treatment group. 6. Proportion of patients taking paracetamol or other standard-of-care treatments for the management of COVID-19 symptoms from Day 0 to Day 5 in each treatment group. Oximetric Endpoint: 7. Time from Day 0 to SpO2 =93% until Day 10 in each treatment group. other Endpoints: 8. Proportion of patients with 100% treatment compliance at Day 5 in each treatment group. 9. Proportion of patients indicating that the suppository form affected treatment compliance in both treatment groups. Exploratory Endpoint: 10. Between treatment group difference in the viral load change from Day 0 to Day 7 in the subgroup of patients who consented to having a third optional virological test.;Timepoint(s) of evaluation of this end point: Safety Endpoint: D22 Virological Endpoint: from Day 0 to Day 3 Clinical Endpoints: from Day 0 to Day 10 and from Day 0 to Day 5 for paracetamol Oximetric Endpoint: from Day 0 to Day 10 Others Secondary Endpoints: D5 Exploratory Endpoint: Day 0 to Day 7 | — |
Countries
France
Contacts
Public ContactBenoit Déprez
Institut Pasteur de Lille
Outcome results
None listed