Status:
UNKNOWN
Intramuscular Effect of Polymerized Type I Collagen on the Cytokine Storm in COVID-19 Patients
Lead Sponsor:
Janette Furuzawa Carballeda
Conditions:
Covid19
Cytokine Storm
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
SARS-CoV-2 infection induces a hyperinflammatory syndrome, causing the acute respiratory distress syndrome, massive lung cell destruction and, as a plausible sequelae, pulmonary fibrosis in COVID-19 p...
Detailed Description
This is a single center, double-blind, placebo-controlled, randomized clinical trial that compares PTIC with placebo in adult outpatients with confirmed COVID-19. The study was approved by the institu...
Eligibility Criteria
Inclusion
- According to the sample size calculation (Cohen's d calculation, using a 50% decrease in IP-10 as the expected effect size), 90 COVID-19 patients will be recruited (symptoms: cough, expectoration, odynophagia, dyspnea with or without fever; radiographic findings by imaging study: inflammatory infiltrates), of both sexes, older than 18 years.
- Participants will be enrolled, even when they do not have a laboratory-confirmed SARS-CoV-2 infection as determined by a positive reverse transcription, polymerase-chain-reaction (RT-PCR) assay result. Patients will be included if they have progressive disease consistent with ongoing SARS-CoV -2 infection.
- Patients with laboratory predictors of mild to severe disease (D-dimer\> 1000 ng/ml; total lymphocytes \<800 cells/µl, creatine phosphokinase\> 2 times upper limit of the normal range; elevated troponins and ferritin\> 300 µg/L) will be included.
- Only those patients who are negative to the intradermal reaction of polymerized type I collagen (subcutaneous application of 0.2 ml of the drug on the forearm, evaluation at 24-48h) will be included.
- Patients with mild to severe disease, peripheral oxygen saturation (SpO2) \<92% on room air, or requiring supplemental oxygen, or mechanical ventilation will be recruited. There will be no limit to the duration of symptoms prior to enrollment.
- Only those patients who are not participating in another protocol and who are not receiving biological therapy and whose standardized therapy is suggested will be included (AmoxiClav or ceftriaxone, or azithromycin, clarithromycin or doxycycline, ivermectin, low molecular weight anticoagulants, paracetamol).
- All patients who agree to participate in the protocol and from whom written informed consent is obtained will be included.
Exclusion
- All patients positive for intradermal reaction to polymerized type I collagen (allergy to study producto) will be excluded.
- All pregnant or breast-feeding patients, patients with chronic kidney disease as determined by calculating an estimated glomerular filtration rate (eGFR), or need for hemodialysis or hemofiltration, patients with cerebrovascular disease, autoimmune disease, cancer, multiorgan failure or immunodeficiencies (HIV, transplant patients, hematological diseases, patients with chemotherapy) will be excluded.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 19 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04517162
Start Date
August 19 2020
End Date
June 19 2021
Last Update
February 17 2021
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico, 14080