Corona Virus Disease 19 (Covid19), Corona Virus Infection, Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
Conditions
Keywords
N-acetylcysteine
Brief summary
The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine NAC in COVID 19 patients.
Detailed description
This is a phase 3 trial enrolling subjects with newly diagnosed Corona virus disease 2019 ( COVID-19) infection who are classified as moderate cases and require hospitalization. Patients meeting eligibility criteria will be randomized either to receive oral N-acetylcysteine or not along with the institution treatment protocol . Treatment efficacy will be assessed using certain endpoints as follows: 1. Markers of inflammation and oxidative stress 2. Length of hospital stay 3. Need for ventilation 4. Mortality rate
Interventions
DRUGN-acetylcysteine
Oral formulation: 600 mg sachets of N-acetylcysteine
Sponsors
Misr International University
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm: those receiving N-acetylcysteine (NAC). One arm is the control group : those not receiving N-acetylcysteine (NAC).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged more than 18 years 2. Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included
Exclusion criteria
1. Known allergy or hypersensitivity to NAC 2. Pregnancy 3. Critically ill or mechanically ventilated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TNF alfa level from baseline | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death | The mean change in TNF alfa is used to assess NAC efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IL-6 level from baseline | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death | The mean change in IL-6 level is used to assess NAC efficacy |
| Change in glutathione peroxidase level from baseline | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death | The mean change in glutathione peroxidase is used to assess NAC efficacy |
| Length of hospital stay | Through study completion ( average 9 months) | Duration of hospital stay for admitted patients |
| Need for mechanical ventilation | Through study completion ( average 9 months) | Whether a patient required mechanical ventilation (intubation) or not |
Countries
Egypt
Outcome results
None listed