A Phase 2 interventional study of Administration of Equine immunoglobulin anti SARS-CoV-2 in Covid19, sponsored by Caja Costarricense de Seguro Social. Completed at 4 sites in Costa Rica. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Caja Costarricense de Seguro Social · Phase 2, Interventional, and Treatment
Reports of the use of plasma from convalescent patients and purified immunoglobulin preparations in respiratory infections by various viral agents and SARS-CoV-2 in severely ill patients suggest that specific neutralizing antibodies may benefit their clinical course. During the previous SARS-CoV epidemic in 2003, preparations of hyperimmune equine serum were produced and demonstrated in vitro viral neutralization. These preparations were also successful in several animal models. Taking advantage of the important trajectory of our country in the study and use of equine hyperimmune serums with neutralizing antibodies for snake venom, preparations of hyperimmune serums against recombinant proteins of SARS-CoV-2 were produced through repeated immunization of horses, a first group of animals was inoculated with the "S" (Spike) protein of the virus and the second group with a mixture "M" of the S1 (Spike) proteins, the N (Nucleoprotein) protein and a construct with epitopes of the S1, E (Envelope) and M (Membrane) proteins, generating two different pharmaceutical preparations.
Objective: Evaluate the efficacy and safety of two hyperimmune equine serum anti-Sars-CoV-2 ("S" and "M") formulations as an addition to the standard therapeutic approach for hospitalized patients with COVID-19 over 18 years of age with the presence of at least 2 risk factors and a symptom onset period not exceeding 10 days.
A total of 52 patients will be included and randomly divided into two balanced groups. On day 1, all participants from each group will receive an intravenous infusion containing 10ml (one vial) of hyperimmune equine anti-Sars-CoV-2 serum labeled as A or B.
Patients will be evaluated clinically, general laboratory, SARS-CoV-2 serologies, SARS-CoV-2 viral load and cytokines level as well as pulmonary ultrasound. Data will be collected for both groups on Days 0 to 7, 10 and 14 or discharge after completion of treatment. The study will end for each participant on the day of discharge from the hospital.
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This study's enrollment of 26 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.
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Exclusion Criteria:
Experimental equine Imunoglobulins antiSARSCov" Formuation S
Biological: Administration of Equine immunoglobulin anti SARS-CoV-2
Experimental equine Imunoglobulins antiSARSCov" Formuation M
Biological: Administration of Equine immunoglobulin anti SARS-CoV-2
The participants will receive premedication with Acetaminophen 500mg PO, Cimetidine300mg IV and Chlortrimeton 10mg IV. Then the investigators will do the Administration of Equine Imunoglobulin anti SARS Cov 2 on day 1 a vial of 10ml of the drug during 1 hour Intravenously. Then the hospitalized participants will be followed until they are discharged.
To evaluate the efficacy and safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M").
Change in clinical status (days requiring supplemental oxygen) between the two treatment groups.
Time frame: 2,3,4,5,7,10,14 Days
To evaluate safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M").
To identify the adverse effects of anti-Sars-CoV-2 type "S" or type "M" equine immunoglobulins administered to patients diagnosed as SARS-CoV-2 positive, with the presence of at least 2 risk factors and a symptom onset period of no more than 10 days.
Time frame: 3 months
Viral load
Change of viral load (number of copies of SARS Cov2 per ml)
Time frame: Days 2,3,4,5,7,10,14
Mortality
Change in mortality between the two treatment groups.
Time frame: days 14, 24
Hospital stay
Change in the overall hospital stay of patients between the two treatment groups.
Time frame: Day 14, 24
ventilatory support
Change in duration of ventilation support in the two treatment groups
Time frame: Day 24
blood levels of immunoglobulins against SARS-CoV-2
Change in titer of immunoglobulins blood levels (UA/ml) against SARS-CoV-2 between the two treatment groups.
Time frame: Days 2,3,4,5,7,10,14
inflammatory markers
Rate of virologic clearance by nasopharyngeal swab at day 10
Time frame: day 10
thrombotic marker levels
7. Difference in the decrease of thrombotic marker levels (D-dimer, fibrinogen, prothrombin time, TTP) on study days 2, 3, 4, 7, 10, and 14 or at discharge between the two treatment groups
Time frame: days 2, 3, 4, 7, 10, and 14
negativization period of RT-PCR on nasopharyngeal swabbing (Reverse transcription polymerase chain reaction)
8. Difference in the number of days elapsed between two negative determinations separated by at least 24 hours in the COVID-19 test by RT-PCR on nasopharyngeal swabbing between the two treatment groups
Time frame: 1 month
SpFI (Partial saturation Oxigen/inspired fraction of Oxigen) gain
Improvement in SAFI (SatO2/FiO2) between the two treatment groups.
Time frame: Days 2,3,4,5,7,10,14
Lung Ultrasound
Change in POCUS score between the two treatment groups. (Minimum: 0 = normal; Maximum: 32= Multiple Lungs Consolidations).
Time frame: days 3,10
Adverse events
Number of adverse events as measured by CTCAE v. 5.0 between the two groups
Time frame: days 2,3,4,5,6,7,10,14,24
Plan to share: No
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Caja Costarricense de Seguro Social