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| Name | Class |
|---|---|
| Misr International University | OTHER |
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The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine (NAC) | Active Comparator | Patients receiving N-acetylcysteine (NAC) |
|
| Control | No Intervention | Patients not receiving N-acetylcysteine (NAC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | Oral formulation: 600 mg sachets of N-acetylcysteine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in TNF alfa level from baseline | The mean change in TNF alfa is used to assess NAC efficacy | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IL-6 level from baseline | The mean change in IL-6 level is used to assess NAC efficacy | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death |
| Change in glutathione peroxidase level from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara M. Sherkawy, B.S.P | Misr International University | Principal Investigator |
| Lamia El Wakeel, Professor | Ain Shams University | Study Chair |
| Mona Schaalan, Professor | Misr International University | Study Director |
| Ayman Moharram, Professor | El Kasr El Einy Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Assema Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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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).
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The mean change in glutathione peroxidase is used to assess NAC efficacy
| from enrollment till the end of treatment at 2 weeks or until hospital discharge or death |
| Length of hospital stay | Duration of hospital stay for admitted patients | Through study completion ( average 9 months) |
| Need for mechanical ventilation | Whether a patient required mechanical ventilation (intubation) or not | Through study completion ( average 9 months) |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |