Clinical trial: Efficacy of Convalescent Plasma Therapy in Patients With COVID-19 (NCT04425915)

Eligibility criteria:
Recipient Inclusion Criteria:

        - Patients with severe COVID-19 will be considered for randomization and will be transfused
        convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19
        defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of
        National Health Commission of China (version 5.0) along with confirmation by real-time
        RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-

          -  Patients on ventilator (in last 24 hours)

          -  Respiratory distress, RR ≥30 beats/min

          -  Oxygen saturation level less than 90 % in resting state

          -  Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg

          -  Lung infiltrates > 50% within 24 to 48 hours

        Recipient Exclusion Criteria:

          -  Patient/ family members who do not give consent to participate in the study.

          -  Patients with age less than 18 years

          -  Patients presenting with multi-organ failure

          -  Pregnancy

          -  Individuals with HIV and Viral Hepatitis and Cancer

          -  Extremely moribund patients with an expected life expectancy of less than 24 hours

          -  Hemodynamic instability requiring vasopressors

          -  Previous history of allergy to plasma

          -  Cirrhosis

          -  Severe renal impairment with GFR< 30ml/min or recipients of RRT, peritoneal dialysis

          -  Patients with uncontrolled diabetes mellitus, hypertension, arrhythmias and unstable
             Angina

        Donor Inclusion Criteria for Plasmapheresis

          -  Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and
             free of symptoms for 14 days.

          -  Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart.

          -  Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs &
             Cosmetics Act 1940 and Rules 1945, amended 11.03.2020

          -  Females who have been pregnant may be tested for anti-HLA antibodies and eligible if
             negative for the same.

        Donors Exclusion Criteria:

          -  Do not fulfill all criteria of donor eligibility for donor Plasmapheresis under

          -  the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020

          -  Females who have been pregnant and have not been tested for HLA antibodies or are HLA
             antibody positive if tested and previously transfused donors (to prevent TRALI)

          -  Donors who have taken steroids during treatment for COVID-19
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction