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Trial - NCT04932941


Column Value
Trial registration number NCT04932941
Full text link
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04932941

First author
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

2021-06-21

Recruitment status
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

key inclusion criteria: - participant is admitted to hospital and has a positive severe acute respiratory syndrome coronavirus type 2 (sars-cov-2) test by standard reverse transcription-polymerase chain reaction (rt-pcr) assay or equivalent test - participant has the presence of any symptom(s) suggestive of moderate or severe systemic illness with covid-19 key

Exclusion criteria
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

- participant, in opinion of the investigator, is not likely to survive >=48 hours beyond day 1 - participant has a diagnosis of asymptomatic covid-19, mild covid-19, or critical covid-19 on day 1 - participant has a documented medical history of infection with hepatitis a, b, c, or with human immunodeficiency virus (with a detectable viral load and cd4 count <500 cells per micro liter), or a documented active infection with tuberculosis. - the participant has clinically significant electrocardiogram (ecg) abnormalities at screening other protocol defined inclusion/exclusion criteria may apply

Number of arms
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

MetrioPharm AG

Inclusion age min
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Bulgaria;France;Hungary;Italy;Romania;Spain;United States

Type of patients
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

132

primary outcome
Last imported at : June 30, 2023, noon
Source : ClinicalTrials.gov

Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14

Notes
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 822, "treatment_name": "Mp1032", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]