COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04405310


Column Value
Trial registration number NCT04405310
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04405310

First author
Last imported at : Dec. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

ANGEL A PEREZ-CALATAYUD, MD

Contact
Last imported at : Dec. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

gmemiinv@gmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-28

Recruitment status
Last imported at : Dec. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - adults 18 to 70 years of age. - serious or critically ill patients confirmed for sars-cov-2 disease (rt-pcr). - meet the criteria for disease with sars-cov-2 disease, phase ii (moderate) and phase iii (severe) . - suspected cytokine release syndrome with hscore 169 points. - presence of severe acute hypoxemia with spo2 <90% in ambient air and / or pao2 / fio2 <300 mmhg. - meet criteria (plain chest tomography or plain chest radiograph) for sars-cov-2 disease. - supplemental oxygen requirement either through the facial store plus reservoir bag, high-flow nasal tips or advanced airway management and invasive mechanical ventilation support.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- patient has no interest in participating in the trial. - bilateral pulmonary infiltrate related to heart failure or other cause of water overload. - virus positive respiratory viral panel other than covid-19 - history of allergy to plasma, sodium citrate, or methylene blue. - patients with a history of autoimmune diseases or selective iga insufficiency. - those patients who are participating in other protocols.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Grupo Mexicano para el Estudio de la Medicina Intensiva

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mexico

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Dec. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

42

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Death

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]