COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04517162

Janette Furuzawa-Carballeda, PhD

jfuruzawa@gmail.com

2020-08-18

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - 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.

- 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.

2

Janette Furuzawa Carballeda

18

80

Mexico

No restriction on type of patients

0: No restriction on type of patients

90

Clinical primary Outcome measure

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 312, "treatment_name": "Collagen-polyvinylpyrrolidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]