Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases (NCT04834089) | Clinical Trial Compass
UnknownPhase 1/2
Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases
Brazil618 participantsStarted 2021-05
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Adults 18 years of age or older;
β. Diagnosis of SARS-CoV-2 infection confirmed by RT-PCR or antigen test no more than 5 days ago;
β. Onset of clinical signs and symptoms of COVID-19 no more than 5 days manifested as:
β. Presenting sudden onset of anosmia and/or ageusia without any other reasonable explanation and/or;
β. Thoracic image by radiography, tomography or ultrasonography compatible with acute clinical symptoms findings of COVID-19 and/or;
β. Acute onset of cough accompanied by fever and/or
β. 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.
β. Oxygen saturation by pulse oximetry β₯92%
Exclusion criteria
β. 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;
β. 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;
β. 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;
What they're measuring
1
Frequency of local and systemic adverse events
Timeframe: 12 hours after product administration
2
Anti-SARS-CoV-2 serum average life
Timeframe: 28 days after product administration
3
Proportion of patients with change in COVID-19 disease progression profile after administration of anti-SARS-CoV-2 serum
β. Severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study;
β. 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;
β. 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;
β. 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.
β. Pregnancy (confirmed by positive Ξ²-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;