A pilot, multiple dose study to evaluate the efficacy and safety of MRx-4DP0004 in hospitalised patients with symptoms of COVID-19 (SARS-CoV-2 infection)

4D pharma plc0 个研究点目标入组 90 人开始时间: 2020年4月9日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•1. Willing and able to sign the informed consent in English and comply with the protocol
•2. Age 18 years or older
•3. Suspected or confirmed COVID-19 as defined by
•a. Positive RNA test for SARS-CoV-2
•b. Presenting with symptoms of COVID-19 as determined by the investigator, and
•c. A score of 4 or 5 on the WHO Ordinal Scale for Clinical Improvement, and
•d. Oxygen saturation of <95% on room air, and
•e. Chest x-ray with evidence of COVID-19 infection e.g. ground-glass opacities
•Up to 2 repeat RNA tests at 2-day intervals may be performed. Participants will be withdrawn from treatment unless at least 1 of 3 RNA tests is positive
•4. Requires admission to hospital
•5. Able to swallow oral capsules
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. Known valvular heart defects, pulmonary hypertension or heart failure
•2. Known cystic fibrosis or chronic obstructive pulmonary disease
•3. Known GI fistula or malabsorption syndrome
•4. Known allergy to ALL of the following antibiotics: ampicillin AND clindamycin AND imipenem
•5. Any other condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the study endpoints
•6. Participants requiring prophylactic antibiotic treatment or antibiotics for a pre-existing condition at enrolment or within the 2 days prior to start of study treatment
•7. Females who are pregnant or breastfeeding or planning to become pregnant during the study or for 30 days after completion of study treatment
•8. Unwilling or unable to follow contraceptive requirements as described in section 4.3.2
•9. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to start of study treatment

发起方