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Trial - NCT05077930


Column Value
Trial registration number NCT05077930
Full text link
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05077930

First author
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Tânia P Costa, Master

Contact
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

tania.p@hospitaldorocio.com.br

Registration date
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

2021-10-14

Recruitment status
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Open label

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

single-center

Study aim
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - hospitalized patients aged ≥18 years. - confirmed diagnosis of covid-19 by rt-pcr or antigen test in respiratory samples. - time between symptom onset and inclusion ≤ 7 days. - enrolled within 5 days of hospitalization. - sign the consent form.

Exclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

- contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure. - history of previous severe allergic reactions to transfused blood products. - limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator. - not currently enrolled another interventional clinical trial of covid-19 treatment. - critically ill patient with covid-19 being treated in intensive care.

Number of arms
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Tânia Portella Costa

Inclusion age min
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Clinical status on a 7-point ordinal scale

Notes
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : April 13, 2022, 11:30 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"}]