|D012127||Respiratory Distress Syndrome, Newborn NIH||0.08|
|D055371||Acute Lung Injury NIH||0.08|
There is one clinical trial.
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.
Description: Change in clinical status (days requiring supplemental oxygen) between the two treatment groups.Measure: To evaluate the efficacy and safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M"). Time: 2,3,4,5,7,10,14 Days
Description: 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.Measure: To evaluate safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M"). Time: 3 months
Description: Change of viral load (number of copies of SARS Cov2 per ml)Measure: Viral load Time: Days 2,3,4,5,7,10,14
Description: Change in mortality between the two treatment groups.Measure: Mortality Time: days 14, 24
Description: Change in the overall hospital stay of patients between the two treatment groups.Measure: Hospital stay Time: Day 14, 24
Description: Change in duration of ventilation support in the two treatment groupsMeasure: ventilatory support Time: Day 24
Description: Change in titer of immunoglobulins blood levels (UA/ml) against SARS-CoV-2 between the two treatment groups.Measure: blood levels of immunoglobulins against SARS-CoV-2 Time: Days 2,3,4,5,7,10,14
Description: Rate of virologic clearance by nasopharyngeal swab at day 10Measure: inflammatory markers Time: day 10
Description: 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 groupsMeasure: thrombotic marker levels Time: days 2, 3, 4, 7, 10, and 14
Description: 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 groupsMeasure: negativization period of RT-PCR on nasopharyngeal swabbing (Reverse transcription polymerase chain reaction) Time: 1 month
Description: Improvement in SAFI (SatO2/FiO2) between the two treatment groups.Measure: SpFI (Partial saturation Oxigen/inspired fraction of Oxigen) gain Time: Days 2,3,4,5,7,10,14
Description: Change in POCUS score between the two treatment groups. (Minimum: 0 = normal; Maximum: 32= Multiple Lungs Consolidations).Measure: Lung Ultrasound Time: days 3,10
Description: Number of adverse events as measured by CTCAE v. 5.0 between the two groupsMeasure: Adverse events Time: days 2,3,4,5,6,7,10,14,24
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports