Clinical trial: Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases (NCT04834089)

Eligibility criteria:
Inclusion Criteria:

          1. Adults 18 years of age or older;

          2. Diagnosis of SARS-CoV-2 infection confirmed by RT-PCR or antigen test no more than 5
             days ago;

          3. Onset of clinical signs and symptoms of COVID-19 no more than 5 days manifested as:

               1. Presenting sudden onset of anosmia and/or ageusia without any other reasonable
                  explanation and/or;

               2. Thoracic image by radiography, tomography or ultrasonography compatible with
                  acute clinical symptoms findings of COVID-19 and/or;

               3. Acute onset of cough accompanied by fever and/or

               4. Acute onset of three or more of the following symptoms: fever, cough, fatigue or
                  general weakness, headache, myalgia, sore throat, runny nose, dyspnea, anorexia
                  or nausea or vomit, diarrhea and mental status change.

          4. Oxygen saturation by pulse oximetry ≥92%

          5. Agree to periodic contacts by phone, electronic means and home visits;

          6. Demonstrate intention to participate in the study, documented by Informed Consent Form
             signature on the part of the participant.

             For the very high risk group:

          7. Being on continuous drug immunosuppressant more than two weeks due to a basic medical
             condition (e.g. transplant or cancer);

             For the high risk group:

          8. To present at least two risk factors for developing serious COVID-19 (Over 60 years of
             age; diabetes mellitus; chronic obstructive pulmonary disease; kidney disease;
             cardiovascular diseases and body mass index ≥ 35).

        Exclusion Criteria:

          1. Presenting COVID-9 in need of oxygen therapy on the moment of study inclusion, in
             other words, score 5 or higher in WHO COVID-19 progression scale;

          2. Behavioral, cognitive or psychiatric disease that, in principal investigator opinion
             or his/her medical representative, affect the participant capacity in understanding
             and collaborating with study protocol requirements;

          3. Any use considered alcohol or drugs abuse in the last 12 months prior to study
             inclusion that caused medical, professional or family problems, as indicated by
             clinical history;

          4. Severe allergic reaction history or anaphylaxis to heterologous serum or product
             components of the study;

          5. To have received heterologous serum or convalescent plasma in the last three months
             before of study inclusion, or planned administration of hemoderivatives or
             immunoglobulin on the next 28 days of study inclusion;

          6. The participant is a team member who is conducting the study or is in a dependent
             relationship with one of the study team members. Dependency relationships include
             close relatives (in other words, sons, partner/spouse, brothers, parents), as well as
             Researcher staff or staff from the location conducting the study;

          7. Any other condition that, in the principal investigator opinion or his/her medical
             representative, could threaten the safety or rights of a potential participant or
             which prevents him from fulfilling with this protocol.

             For female:

          8. Pregnancy (confirmed by positive β-hCG test), breastfeeding and/or expressing an
             intention to have sexual practices with reproductive potential without using a
             contraceptive method within four weeks of the product administration;

             For stages A and B:

          9. Previous immunization with vaccine against COVID-19
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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? Entailment