Clinical trial: Potential Efficacy of Convalescent Plasma to Treat Severe COVID-19 and Patients at High Risk of Developing Severe COVID-19 (NCT04347681)

Eligibility criteria:
Inclusion Criteria:s

          1. Recipients:

             We will use the confirmed case definition of SARS-CoV-2 infection (COVID-19) with
             POSITIVE rRT PCR test for SARS-CoV-2 "using one of the SFDA approved kit used in KSA"
             as per current MOH / SCDPC (Waqayah) guidelines (derived from WHO and CDC ).

               1. 18 or older

               2. Patient with COVID 19 confirmed as per case definition of CDC or MOH/Waqayah

               3. Must have been requiring ICU care or severe or immediately life-threatening care:

             i. Patient requiring ICU admission. ii. Severe disease is defined as:

               1. Dyspnea

               2. Respiratory frequency ≥ 30/min

               3. Blood oxygen saturation ≤ 93%

               4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300,
                  and/or Lung infiltrates > 50% within 24 to 48 hours iii. Life-threatening disease
                  is defined as:

               1. Respiratory failure

               2. Septic shock, and/or

               3. Multiple organ dysfunction or failure

          2. Donors:

               1. 18 or older

               2. Recovery from Prior confirmed COVID-19 diagnosis through NEGATIVE rRT PCR test
                  for SARS-CoV-2 from blood or nasopharyngeal swab - FDA IND guidance or the MOH
                  updated recovery protocol 15.20.22.23

               3. Complete Clinical Recovery from COVID-19 at least 14 days prior to donation (FDA
                  IND guidance15)

               4. All MOH criteria for a fit donor will be followed prior to donation.

               5. All Transfusion Transmissible Infections (TTI) markers on the donor blood are
                  negative as per current MOH routine donor screening regulations

        Exclusion Criteria:

          1. Recipients:

               1. Negative or non-conclusive test COVID-19 rRT PCR test for SARS-CoV-2

               2. Mild symptoms

               3. Hospitalization not requiring ICU admission

          2. Donors:

               1. Unfit to donate.

               2. Multiparous or pregnant females.
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.
Subject must be at most 85 Years

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