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Trial - NCT04332835


Column Value
Trial registration number NCT04332835
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04332835

First author
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

Juan M Anaya Cabrera, MD, PhD

Contact
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

anayajm@gmail.com

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

2020-04-03

Recruitment status
Last imported at : Dec. 1, 2020, 12:40 p.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:fulfilling all the following criteria olerder than 18. hospitalized participants with diagnosis of covid 19 by real time - polymerase chain reaction. severe cases according to the official guideline "pneumonia diagnosis and treatment scheme for novel coronavirus infection (trial version 7)". sequential organ failure assessment score (sofa) < 6. ability to understand and the willingness to sign a written informed consent document.

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

female subjects who are pregnant or breastfeeding. patients with prior allergic reactions to transfusions. critical ill patients in intensive care units with requierment of invasive mechanical venitlation. patients with surgical procedures in the last 30 days. patients with active treatment for cancer (radiotherapy or chemotherapy). hiv diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals). demonstrated coinfection that explains the patient's symptoms end-stage chronic kidney disease (glomerular filtration rate <15 ml / min / 1.73 m2). child pugh c stage liver cirrhosis. high cardiac output diseases. autoimmune diseases or immunoglobulin a nephropathy. patients have any condition that in the judgement of the investigators would make the subject inappropriate for entry into this study.

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

Universidad del Rosario

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

60

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

Colombia

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

Moderate disease at enrollment

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

3: Moderate disease at enrollment

Total sample size
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

92

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

Change in Viral Load;Change in Immunoglobulin G COVID-19 Titers

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/Phase 3

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"}]