COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04710199

Jose Manuel Lomas, MD

jlomascabezas@yahoo.es

2021-01-14

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - subjects aged ≥ 18 years. - infection confirmed by sars-cov-2 by polymerase chain reaction (pcr) at least 3 days before randomization. - hospitalized or emergency patient in hospitalization phase. - mild / moderate pneumonia, with fever, persistent cough and severe asthenia, confirmed by imaging tests (conventional radiology or computerized axial tomography (ct)) with ambient air oxygen saturation (sato2)> 94%. - less than 12 days from the onset of symptoms. - women of childbearing potential must have a negative serum or urine pregnancy test prior to inclusion in the study and must commit to using highly effective contraceptive methods (intrauterine device, bilateral tubal occlusion, vasectomized partner, and sexual abstinence). - accepts written consent or oral informed in the case that due to the relevant security protocols, written consent is not possible.

- patient with severe pneumonia confirmed by imaging test (conventional radiology or computerized axial tomography (ct)) with ambient air oxygen saturation (sato2) ≤94%. - another acute active infection other than that produced by sars-cov-2. - chronic renal failure (estimated glomerular filtration ≤ 30 ml / min / 1.73 m2 or receiving renal replacement therapy in any of its modalities). - known hiv infection. unless the patient has> 500 cd4 + / mm3 and an undetectable viral load for more than 6 months. - active co-infection with known hepatitis b or c viruses. - cirrhosis, portal hypertension and / or hypersplenism of any etiology. - past or current neoplasms subsidiary to treatment with steroids, immunomodulators or chemotherapy - laboratory abnormalities. - concomitant use of drugs with major pharmacological interactions with the study drugs, according to the respective technical specifications of the products. - pregnancy.

2

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

18

100

Spain

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

44

Evaluate the efficacy of Maraviroc in SARS-CoV-2 infected patients hospitalized for COVID-19 using the Ordinal scale.

None

Phase 2

[{"arm_notes": "", "treatment_id": 767, "treatment_name": "Maraviroc", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]