COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04537130

Federico Nepote

investigacion@mfar.net

2020-09-03

Unknown

RCT

Randomized

Parallel

Open label

single-center

Long covid

inclusion criteria: written informed consent approved by the investigator's institutional review board (irb)/independent ethics committee (iec), prior to the performance of any trial activities. age 18 years or older. patients with positive rt-pcr or igm/igg blood test for sars-cov-2 prior to the inclusion in the study. patients that have pneumonia associated to sars-cov-s infection prior to randomization. patients having respiratory dysfunction after sars-cov-2 infection and abnormal ct chest imaging. patients previously under high flow nasal cannula or non-invasive ventilation, or supplementary oxygen, during hospitalization for covid-19. increased egf level (more than 200 picogram/ml). negative serum pregnancy test at screening for women of childbearing potential. highly effective contraception for both male and female subjects throughout the study and for at least 3 months after last imp treatment administration if the risk of conception exists.

patients with previous ipf, autoimmune disease or connective tissue diseases (ctd). known of previous clinically significant pulmonary abnormalities that may interfere with the measurement of study variables in the opinion of the investigator as ild, or chronic respiratory failure. other investigational therapy received within 1 month or 6 half-lives (whichever was greater) in the context of a clinical study. included a physician's decision that involvement in the trial was not in the patient's best interest. presence of any condition that would not allow the protocol to be followed safely. any mental health condition, that may interfere in the normal development of the study according to physician criteria. known hypersensitivity to the trial medication or its components other disease that may interfere with testing procedures or may put the patient at risk when participating in this trial in the judgment of the investigator. women who are pregnant, nursing, or who plan to become pregnant while in the trial. women of childbearing potential* not willing or able to use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after experimental treatment administration. a list of contraception methods meeting these criteria is provided in the patient information. active alcohol or drug abuse in the opinion of the investigator. any other reason that the investigator deems to be incompatible with the patient'sparticipation in study.

2

Instituto Oncológico Dr Rosell

18

100

Spain

Patients recovered from covid

N/A

40

Safety (Frequency/severity of AEs)

None

Phase 1

[{"arm_notes": "2 or 5", "treatment_id": 642, "treatment_name": "In01 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]