COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04343963

Sergio I Valdés-Ferrer, MD, PhD

sergio.valdesf@incmnsz.mx

2020-04-14

Not reported

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: adult patients (≥18 years old) signed informed consent by the patient or designated legal representative confirmatory laboratory test for sars-cov-2 / covid-19 infection pneumonia confirmed by imaging studies agree to venous blood collection according to the protocol need for hospitalization with increased mortality criteria according to published observations, including one or more of the following severity criteria according to the treating medical team: a. dyspnoea b. lung infiltrates> 50% of lung fields by ct c. a ratio of partial pressure arterial oxygen (pao2) to the fraction of inspired oxygen (fio2) <300 mmhg d. pulse oximetry <90% to ambient air, or a 3% drop in baseline oximetry, or need to increase supplemental oxygen due to chronic hypoxia, as well as the need for supplemental oxygen according to medical judgment and, alteration of one or more of the following laboratory studies at the time of hospital admission: i. d-dimer >1 ug/ml ii. ferritin level >300 ng/ml iii. c-reactive protein (crp) >3mg/l iv. lactate dehydrogenase (ldh) >245 u/l v. lymphopenia <800 cells/ul vi. creatine kinase (ck) level >800 iu/l

pyridostigmine allergy if female, pregnancy or breastfeeding meet the following critical illness criteria before signing informed consent and taking the first dose of study medication: . need for mechanical ventilation . admission to the icu for any reason . meet criteria for sepsis or septic shock concomitant autoimmune diseases known immunodeficiency (including hiv infection) need for mechanical ventilation before signing informed consent and taking the first dose of study medication inability to administer orally / enterally use of immunosuppressants or immuno-modulators in the preceding 28 days, including chemotherapeutics and steroids, unless recommended by the treatment medical team as part of the therapeutic approach for sars-cov-2 infection participation in interventional clinical trials in the preceding 28 days (however, participation in observational trials or those with no therapeutic intervention, is allowed)

2

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

18

None

Mexico

Severe disease at enrollment

6: Severe disease at enrollment

436

Critical condition or death;IL-6

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1045, "treatment_name": "Pyridostigmine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]