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Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. The aim of the current study is comparing the efficacy and safety of combining remdesivir and ivermectin versus using remdesivir alone in patients with severe COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir only | No Intervention | (Dose 200 mg day one, 100 mg daily days 2-5), duration may extend to 10 days of remdesivir (200 mg day one, 100 mg daily days 2-10) | |
| Combination remdesivir plus ivermectin group | Experimental | (The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | (The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1- Improvement in level of oxygenation | Change in partial pressure of Oxygen and oxygen saturation | By arterial blood gas and non-invasive pulse oximeter at date of randomisation, after 1 hour then on daily bases in stable cases till time of patient discharge or death |
| 2- Need for ventilator support | either noninvasive or invasive mechanical ventilation. | From date of randomisation to patient discharge from hospital or death. |
| 3- Length of hospital stay | duration of admission in days | From date of randomisation to date of patient discharge from hospital or death. |
| 4- Development of complication | allergic reactions, arrhythmia, hepatic toxicity..... | From starting to the end of ivermectin therapy (0 to the end of 4th day) |
| 5- Mortality | mortality rates in both groups | Through study completion, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32251768 | Background | Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3. | |
| 32679055 | Background | Pizzorno A, Padey B, Dubois J, Julien T, Traversier A, Duliere V, Brun P, Lina B, Rosa-Calatrava M, Terrier O. In vitro evaluation of antiviral activity of single and combined repurposable drugs against SARS-CoV-2. Antiviral Res. 2020 Sep;181:104878. doi: 10.1016/j.antiviral.2020.104878. Epub 2020 Jul 15. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |