General information Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Safety and efficacy study of the monoclonal antibody nimotuzumab in the treatment of severe patients with SARS-CoV-2 pneumonia. (COVID-19)
Acronym of Scientific Title:
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
Source(s) of monetary or material support:
Center of Molecular Immunology (CIM), Cuban Ministry of Public Health (MINSAP)
Authorization for beginning Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Principal investigator Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
Medical Specialty :
Second Degree Specialist in Intensive Therapy
Affiliation:
Clinical Surgical Teaching Hospital "Julio Trigo Lopez"
Postal address:
Calzada de Bejucal No. km 7½, Reparto La Esperanza, Parraga, Arroyo Naranjo
Telephone:
+53-76438359
+53-55921867
Clinical sites to participate Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Clinical sites:
Havana, Teaching Surgical Clinical Hospital "Dr. Salvador Allende", Jorge Jimenez Armada, MD., Second Degree Specialist in Intensive Therapy Specialist. Head of the COVID-19 Group of Experts
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
Health condition and Intervention Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Health condition(s) code:
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Betacoronavirus
Acute Disease
Critical Care
Health condition keyword:
Intervention(s):
Nimotuzumab (Experimental group): Nimotuzumab will be presented in bulbs of 50 mg / 10 mL, boxes of 4 bulbs. Up to three doses of Nimotuzumab will be administered by intravenous route (antecubital vein), the first two mandatory and, the third if there is no clinical improvement.
First dose: 200 mg of Nimotuzumab diluted in 250 mL of 0.9% saline solution, (total volume of 290 mL), in a 2-hour infusion.
Second dose: 100 mg of Nimotuzumab diluted in 250 mL of 0.9% saline solution, (total volume of 270 ml), in a 2-hour infusion. The second dose will be administered 72 hours after the first infusion.
If the patient is still hospitalized in the Intensive Care Unit (ICU) and, shows signs of progressive disease, a third dose may be administered 72 hours after the second dose. The preparation of the infusion will be carried out in the same way as in the second administration.
Intervention code:
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Administration, Intravenous
Outcomes and Timepoint Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Safety
1. Serious Adverse Events-SAE (Percentage of patients who developed SAE according to the CTCAE v5.0 classification). Measurement time: During hospitalized time
2. Clinical and laboratory adverse events (The frequency distribution of AD appearance, type of event and body system will be determined. Duration, intensity, result, attitude and causal relationship of the AE will be identified. Measurement time: 0, 24, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days.
Effect:
3. Rate of deceased patients in 14 days following the use of the drug. Measurement time: at 14 days
4. Rate of patients with disease progression (clinical or radiological worsening in the classification of clinical status). Measurement time: 0, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days.
Key secondary outcomes:
1. Pulmonary function (Rate of patients who improve the PO2/FiO2 ratio, Oro-tracheal intubation rate, measured as the rate of patients requiring intubation, Duration of mechanical ventilation or time to deteste, Chest X-ray). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days
2. Inflammation Markers (NLR, IL6, Interferon gamma, C-reactive protein). Measurement time: Day 0, at 72 hours, 120 and, 168 hours after the use of the drug.
3. Clinical Laboratory (Hemoglobin (Hb), Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrosedimentation, Triglycerides, Ferritin, Creatinine, LDH (Lactate dehydrogenase), Amino-aspartate transferase, Pyruvic glutamic transferase, Complete Pyruvic Coagulogram, according the lab units). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days
Selection criterias Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Inclusion criteria:
1.- Any gender and skin color
2.- Age equal to or greater than 19 years
3.- Patients in a severe stage of COVID-19 of the disease defined by any of the following conditions:
- Patients who have SpO2 <94% or patients in need of oxygen therapy to maintain SO2> 93% or
- Patients with a PaO2 / FiO2 ratio <300 mm Hg or
- Patients with a respiratory rate> 30 inspirations / min,
- Patients with infiltrate in more than 50% of both lung fields
Exclusion criteria:
1.- Pregnant or lactating women.
2.-Under 19 years.
Study design Section to complete information about the characteristics of the study design.
Contact for public queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
Specialty:
Specialist in Biochemistry and Clinical Trials. Doctor of Health Sciences
Affiliation:
Center of Molecular Immunology
Postal Address:
216 and 15. Atabey, Playa.
Contact for scientific queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
Specialty:
Specialist in Biochemistry and Clinical Trials. Doctor of Health Sciences
Affiliation:
Center of Molecular Immunology
Postal Address:
216 and 15. Atabey, Playa
Data Sharing Section to complete the data related to the data sharing plan.
Research Ethics Committees Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Teaching Surgical Clinical Hospital "Julio Trigo Lopez"
Teaching Surgical Clinical Hospital "Dr. Salvador Allende"
Status of evaluation date of Ethic Committee:
Postal address of Ethic Committee :
Calzada de Bejucal km 7½, Reparto La Esperanza, Parraga, Arroyo Naranjo, ZC 10900, Havana. Cuba
Calzada del Cerro 1551 corner Dominguez., Cerro, ZC 12000, Havana. Cuba
Telephone:
+53-76438359
+53-78776354
Email:
hosjtrigo@infomed.sld.cu
sallende@infomed.sld.cu
About study completion Section to complete the data related to the study completion.
Registration and Update Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
