PLASMA TREATMENT TO ASYMPTOMATIC PATIENT WITH COVID-19 INFECTIO

Not Applicable

Recruiting

• Conditions: COVID-19 infection; COVID-19; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus; Severe Acute Respiratory Syndrome

• Registration Number: RPCEC00000323
• Lead Sponsor: Institute of Hematology and Immunology Dr. Jose Manuel Ballester Santovenia”

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-03
• Study Completion: 2020-12-12
• Results First Posted: 2021-03-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult with SARS-CoV2 infection diagnosed by RT-PCR.
2. Remain asymptomatic with SARS-CoV2 positive PCR for more than 30 days.
3. That the antibody kit tests do not detect antibodies.
4. That there is no history of anaphylaxis reactions with blood products.
5. That at the clinical evaluation by the attending physician there are no contraindications for plasma transfusion.
6. That the patient or their relatives give their informed consent to receive this donation.

Exclusion Criteria

None

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Improvement of the respiratory failure (It will measure as an increase in the partial pressure of oxygen above 60 mmHg or oxygen saturation greater than 90.7%). Measurement time: 48 hours after treatment <br>2. Clinical improvement (It will measure through the change in the classification from Severe to From Care and From Care to Open Room). Measurement time: 72 hours after treatment <br>3. Improvement of at least two complete blood count parameters (It will measure as any positive difference in Hemoglobin levels, differential white blood cell count and platelet value). Measurement time: 48 and, 72 hours after treatment<br>4. Negativization of the PCR (Yes, No). Measurement time: 7 days after the treatment

Secondary Outcome Measures

Name	Time	Method
Adverse Events-AE (Occurrence of any AE in the subject (Yes, No), Type of AE (Name of the adverse event), Location (Local, Systemic), Time of onset (Immediate, Late), Duration of AE (Less than a day, Greater than a day), Previous knowledge (Expected, Unexpected), AEs intensity (Mild, Moderate, Severe), AEs severity (Serious, Not serious), AEs result (Recovered, Improved, Persists, Sequelae), Causal relationship (Very Probable, Probable, Possible, Unlikely, Not related, Not evaluable), Outcome of the AE (Recovered, Not Recovered, Recovered with sequelae, Death, Unknown), Attitude towards treatment of study (Continuation, Definitive interruption). Measurement time: At the end of treatment