Prague Med. Rep. 2025, 126, 121-138
Development, Implementation, Pharmacokinetic and Safety Evaluation of an Immunotherapeutic Treatment for COVID-19: Double-blind Randomized Placebo-controlled Trial
, Silvia Miranda3, Adolfo Rafael De Roodt1, Roxana Salvi2, Ivana Colaianni2, Elizabeth García2, Guillermo Bramuglia3, Leandro Calderón1, Diego Mazza1, Laura Lanari1, Oscar Perez1, Matias Fingermann1, Guillermo Temprano1, Guillermo Di Girolamo3, Claudio Bonel1, José Cristian Dokmetjian1
1Administración Nacional de Laboratorios e Institutos de Salud “Dr. Carlos G. Malbrán” (ANLIS-Malbrán), Instituto Nacional de Producción de Biológicos (INPB), Buenos Aires, Argentina
2Hospital General de Agudos Donación Francisco J. Santojanni, Buenos Aires, Argentina
3Instituto Alberto C. Taquini de Investigaciones en Medicina Traslacional (IATIMET), Facultad de Medicina, Universidad de Buenos Aires, Buenos Aires, Argentina
Received January 21, 2025
Accepted August 27, 2025
Passive immunotherapy has been evaluated in many infections. The present study aims to evaluate purified F(ab’)2 fraction of equine hyperimmune IgG (anti-SARS-CoV-2) in the treatment of coronavirus lung disease. Patients with coronavirus disease of 2019 (COVID-19) with World Health Organization (WHO) score 3, 4 or 5 up to 72 hours of evolution from the onset of symptoms were included. They were randomly assigned to anti-SARS-CoV-2 or placebo. Follow-up was performed for 28 days to assess efficacy, safety, pharmacokinetics, detection of anti-horse antibodies, circulating cytokines and determination of anti-SARS neutralizing activity. The 20 initial patients (44±14 years) were included. On the third day of treatment there was an improvement (P=0.02) in arterial saturation (95±1.6 vs. 93±2.5%) with increasing differences over time between treatments (day 8: 97±0.1 vs. 94±0.3%). The length of oxygen therapy treatment was 2±0.8 vs. 3±0.9 (0.048) in patients falling within WHO 5 category (no difference to WHO 4). Mean hospitalization was 13±2.5 vs. 14±0.8 days (P=0.095) and time to clinical improvement was 2±0.5 vs. 3±0.9 days (P=0.048) in patients with initial 5 WHO category, with no differences to patients who started with WHO stage 4. The time to nasal swab negativization was 10±2.1 vs. 12±0 day (P=0.015). No adverse reactions or intercurrences were detected. All patients presented heterophile antibodies without clinical correlate. The new treatment shows improvement in arterial saturation (days 3 to 12), and a decrease on detectable viral RNA (days 8 to 11) with good pharmacokinetic and safety profile.
Keywords
Immune sera, Antitoxin, Antibodies, SARS-CoV-2, Immunoglobulin fragments, Immunotherapy, Equine immune sera.
Funding
This study was supported by the Instituto Nacional de Producción de Biológicos and ANLIS-Malbrán, a public state administration that groups the national health institutes.
References
Copyright
This is an open-access article distributed under the terms of the Creative Commons Attribution License.
