Controlled randomized clinical trial on using Ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq

Hashim et al., Iraqi Journal of Medical Science, 19:1, NCT04591600, Oct 2020

4th treatment shown to reduce risk in August 2020, now with p < 0.00000000001 from 106 studies, recognized in 24 countries.

Lower risk for mortality, ventilation, ICU, hospitalization, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

6,200+ studies for 200+ treatments. c19early.org

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RCT 70 ivermectin+doxycycline patients and 70 control patients showing reduced time to recovery and reduced mortality with treatment. Earlier treatment was more successful. For ethical reasons, critical patients were all in the treatment group. NCT04591600 (history).

This is the 7th of 53 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.000000087.

This is the 14th of 106 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001.

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risk of death, 91.7% lower, RR 0.08, p = 0.03, treatment 0 of 59 (0.0%), control 6 of 70 (8.6%), NNT 12, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), excluding non-randomized critical patients, primary outcome.

risk of death, 67.1% lower, RR 0.33, p = 0.16, treatment 2 of 70 (2.9%), control 6 of 70 (8.6%), NNT 18, odds ratio converted to relative risk, including critical patients that were always allocated to treatment.

risk of progression, 83.1% lower, RR 0.17, p = 0.07, treatment 1 of 59 (1.7%), control 7 of 70 (10.0%), NNT 12, excluding non-randomized critical patients.

risk of progression, 57.4% lower, RR 0.43, p = 0.20, treatment 3 of 70 (4.3%), control 7 of 70 (10.0%), NNT 18, odds ratio converted to relative risk, including critical patients that were always allocated to treatment.

recovery time, 40.7% lower, relative time 0.59, p < 0.001, treatment 70, control 70.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Hashim et al., 26 Oct 2020, Single Blind Randomized Controlled Trial, Iraq, peer-reviewed, 7 authors, study period 1 July, 2020 - 14 October, 2020, dosage 200μg/kg days 1-2, some patients received a third dose on day 8, this trial uses multiple treatments in the treatment arm (combined with doxycycline) - results of individual treatments may vary, trial NCT04591600 (history).

Controlled Randomized Clinical Trial on Using Ivermectin with Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq

Hashim A Hashim, MD Mohammed F Maulood, MD Chasib L Ali, Anwar Rasheed, MSc Dhurgham F Fatak, BSc Khulood K Kabah, BSc Ahmed S Abdulamir

Iraqi Journal of Medical Sciences, doi:10.22578/ijms.19.1.14

COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try repurposed old drugs on COVID-19. Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200 µg/kg PO of Ivermectin per day for 2-3 days along with 100 mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy, which is (vitamin C, D, and zinc, azithromycin, dexamethasone and oxygen supply if needed). The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters. Among all patients and among severe patients, 3/70 (4.28%) and 1/11 (9%), respectively progressed to a more advanced stage of the disease in the Ivermectin-Doxycycline group versus 7/70 (10%) and 7/22 (31.81%), respectively in the control group (P>0.05). The mortality rate was 0/48 (0%), 0/11 (0%), and 2/11 (18.2%) in mild-moderate, severe, and critical COVID-19 patients, respectively in Ivermectin-Doxycycline group versus 0/48 (0%), and 6/22 (27.27%) in mild-moderate and severe COVID-19 patients, respectively in standard therapy group (p=0.052). Moreover, the mean time to recovery was 6.34, 20.27, and 24.13 days in mild-moderate, severe, and critical COVID-19 patients, respectively in Ivermectin-Doxycycline group versus 13.66 and 24.25 days in mild-moderate and severe COVID-19 patients, respectively in standard therapy group (P<0.01). It is concluded that Ivermectin with doxycycline reduced the time to recovery, the percentage of patients progress to more advanced stage of disease, and reduced mortality rate in severe patients from 22.72% to 0%.

Author contribution Dr. Hashim and Dr. Maulood applied the intervention on patients and collected data. Dr. Abdulamir, Dr. Ali, Rasheed, Fatak, and Kabah designed the clinical trial and the study. Dr. Ahmed S. Abdulamir wrote the manuscript. Conflict of interest Authors confirm that there is no conflict of interest concerning this research and the written manuscript.

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Late treatment
is less effective