COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04448756

US Medical Information

eMediUSA@emdserono.com

2020-06-26

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - participant provides signed informed consent prior to the initiation of any study assessments - has laboratory-confirmed sars-cov-2 infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization - has chest imaging consistent with covid-19 pneumonia (as per locally accepted guidelines) if chest imaging is not available during screening, please discuss with medical monitor or designee regarding evidence of probable covid-19 pneumonia for study participant eligibility - not on mechanical ventilation or ecmo - has an spo2 less than (<) 94 percent in room air and able to maintain a partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) greater than or equal to (>=) 150 (or equivalent spo2/fio2 >=190) with a maximum fio2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 liter), assess their current baseline oxygen requirements for eligibility - requires hospitalization - other protocol defined inclusion criteria may apply

- any condition that could interfere with the study objectives, conduct or evaluation in the opinion of the investigator or sponsor or designee - significantly uncontrolled medical illness (eg, cardiovascular disease, hypertension, diabetes mellitus, obstructive lung disease, neurological associated with seizures (example: cerebrovascular accident/stroke, acute brain infection, traumatic brain injury, progressive brain disease, congenital brain disease or neuropsychiatric disorder) - known active infection other than covid-19 - pregnancy or breastfeeding - other protocol defined exclusion criteria may apply

3

EMD Serono Research & Development Institute, Inc.

18

70

Brazil;Philippines;United States

Severe disease at enrollment

6: Severe disease at enrollment

149

Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements;Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters;Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0;Time to Recovery

None

Phase 2

[{"arm_notes": "", "treatment_id": 761, "treatment_name": "M5049", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 761, "treatment_name": "M5049", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]