COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000045-41/FR

Institut Pasteur de Lille - Benoit Déprez

benoit.deprez@univ-lille.fr

2021-04-12

Completed

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

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.

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.

2

Institut Pasteur de Lille

50

100

France

Mild disease at enrollment

1: Mild disease at enrollment

686

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.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 299, "treatment_name": "Clofoctol", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]