Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases
Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases
Phase I/II Randomized Clinical Trial to evaluate the safety, pharmacokinetic and efficacy of
 Anti-SARS-CoV-2 hyperimmune serum.

 The study will include patients at early stage of COVID-19 with increased risk for severe
 disease due to underlying medical conditions to determine the utility of an equine
 heterologous serum anti-SARS-CoV-2 to avoid progression to a severe COVID-19
Phase I/II Clinical Trial, randomized, multicentric, on three stages (A, B and C) to evaluate
 the safety, pharmacokinetic and efficacy of Anti-SARS-CoV-2 serum and dose escalation.

 The study will be in three stages:

 Stage A: 30 kidney transplanted participants (very high risk), where 15 will received 1 vial
 (5 mL) and 15 will received 2 vials (10 mL) of serum;

 Stage B: 30 immunocompetent participants with at least 2 risk factors for severe disease
 (high risk) who will receive the dose selected by stage A;

 Stage C: 558 participants, of very high risk and high risk, compared with placebo in
 allocation 2:1 (endpoint-driven design)

 Allocation type Open study without allocation of randomization on Stages A and B Randomized
 allocation with placebo comparator in Stage C.

 Recruitment Status: On planning

 Date of 1st recruitment Expected: April 2021

 Target sample siz 618 (30/30/538) participants

 .
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