Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT04560205
Eligibility Criteria:
Inclusion Criteria:
* All patients of all ages, males and non-pregnant females who will be diagnosed COVID-19 positive by RT-PCR.
* Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
* Patient \>55 years of age Or Age \<55 with comorbid condition who will be unable to maintain O2 sat \> 93% with 5-7 liter of oxygen.
* Or Patient \< 55 with no comorbid conditions, who will be unable to maintain O2 sat \> 93% with 7-10 liter of oxygen.
* Respiratory rate \> 30-35/ min and \>50% of radiological involvement of lung with typical lesions.
* Along with \> 50% deranged ≥ 2 biochemical markers CRP \> 50 mg/l, LDH \> 1000U/L, D.Dimer \> 1mg/l or 1000 ng/ml, Serum Ferritin \> 1000 ng/ml or mcg/l will be included in clinical trial.
Exclusion Criteria:
* Patient who will not require supplemental oxygen during hospital stay.
* Patients on Invasive mechanical ventilation (IMV).
* Patients with respiratory rate \< 30/mins and whose laboratory findings will not be deranged \> 50%.
* Patients with improving radiological findings will be excluded.
* Patients suffering from Active TB
* Herpes zoster
* Multiple sclerosis,
* Allergic to tocilizumab
* Presences of chronic renal failure \> 4 stage, GFR \< 30ml/min/1.73m2.
* ALT/AST \> 5 times than normal values.
* Presences of neutropenia \< 500/mm3.
* Platelets count less than 50 ×103 /µl.
* Complicated diverticulitis/ intestinal perforation.
* Immune-suppressive anti- rejection therapy.
* Pregnant women.
* Previous MI/ IHD, IV heart failure.
* Psychiatric patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
80 Years
Study:
NCT04560205
Study Brief:
Protocol Section:
NCT04560205