Covid19
Conditions
Brief summary
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.
Interventions
(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)
Sponsors
Study design
Eligibility
Inclusion criteria
* Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).
Exclusion criteria
* patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance \< 30 ml/hr), raised liver enzymes\> 3 folds of normal, arrhythmia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1- Improvement in level of oxygenation | 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 | Change in partial pressure of Oxygen and oxygen saturation |
| 2- Need for ventilator support | From date of randomisation to patient discharge from hospital or death. | either noninvasive or invasive mechanical ventilation. |
| 3- Length of hospital stay | From date of randomisation to date of patient discharge from hospital or death. | duration of admission in days |
| 4- Development of complication | From starting to the end of ivermectin therapy (0 to the end of 4th day) | allergic reactions, arrhythmia, hepatic toxicity..... |
| 5- Mortality | Through study completion, an average of 3 months | mortality rates in both groups |