COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04358783


Column Value
Trial registration number NCT04358783
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04358783

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

Adrian Camacho-Ortiz

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

Eduardo Pérez Alba, md.eduardo.perez@gmail.com (PI email not reported)

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

2020-04-24

Recruitment status
Last imported at : May 28, 2021, 12:32 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

single-center

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

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: men or women ≥18 years. if you are a woman of childbearing age, you must agree to practice abstinence or to use an effective method of contraception during the study period. vascular access suitable for administration of hemocomponents. sars-cov-2 positive rt-pcr. negative pregnancy test in case of a woman of reproductive age signing of evidentiary document of informed consent. hospital admission for sars-cov-2 pneumonia with supplemental oxygen requirements. subjects who access the storage of biological samples for future examination.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

respiratory rate >30 rpm, so2 <93%, pao2/fio2 <200 despite intervention with oxygen therapy after 60 minutes of hospitalization. new alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital. pam ≤ 65mmhg despite initial resuscitation on arrival at the centre. pregnant or breastfeeding patients. patients that the investigators consider inappropriate to participate in the clinical trial contraindication to transfusion or history of previous severe reaction to blood products. have received any blood products in the last 120 days.

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

Hospital Universitario Dr. Jose E. Gonzalez

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

None

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

Moderate/severe disease at enrollment

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

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

31

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

Early all-cause mortality

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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]