Status:
UNKNOWN
Pyridostigmine in Severe SARS-CoV-2 Infection
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
We will evaluate low-dose pyridostigmine as add-on therapy to best medical care in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and its related Coronavirus Dise...
Detailed Description
The study will be divided into two phases, each with different variables to evaluate, as described below: The primary objective of the first phase (proof-of-concept) will be to evaluate the effect of...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT04343963
Start Date
April 4 2020
End Date
April 30 2021
Last Update
July 7 2020
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, Mexico, 14080