massimaux | 4 points
Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients (Pakistan, September 2020): Small randomized control trialYet another (25+25 patient) study showing ineffectiveness. Damn it.
Objectives: To assess the efficacy of Ivermectin in mild cases of COVID-19 patients on the basis of predefined assessment criteria.
Study Settings: Fatima Memorial Hospital, Lahore
Study Design: Open label randomized control trial.
Duration of Study: From 1st May, 2020 to 30th June, 2020.
Patients & Methods:
Sample size and technique: Sample size was 50 patients; 25 patients were kept in control group and 25 patients were kept in experimental group.
Results: There were total 50 patients, divided into two groups case and control group. The mean age of the participants was 40.60 ± 17 and out of those 31 (62%) were male and 19 (38%) were females. Cough was observed more in case group (p= 0.049). Fever, myalgias and dyspnea were the commonest symptoms in both the groups (p= 1.000). Diarrhea and vomiting were more common in control group (p=0.0001, p= 0.042 respectively). On follow up at day 7, patients were stratified as asymptomatic and symptomatic. Amongst the case group, out of 25 patients, 16(64%) patients were asymptomatic and rest of the 9(36%) patients was asymptomatic. In control group, out of 25 patients, 15(60%) patients were asymptomatic and rest of the 10(40%) patients was asymptomatic. p-value (0.500). Statistically there was no significant difference between case group who were given ivermectin along with symptomatic treatment and control group who were only given symptomatic treatment without ivermectin, being asymptomatic on day 7 at follow up. p-value (0.500)
[-] Ok-Film-9049 | 1 points
If IVM works it is either as an antiviral and this ability will need to be tested on day 1 of symptoms or ideally just after exposure, this study will have been too late.
If it works as an anti-inflammatory/ blocker of micro thrombi then this will need to be tested on severe cases, or those likely to develop to severe. if we consider that very few people really go down this severe route, this doesn't really address this issue by using mild cases i.e. those who have had covid for a while but not progressing in a serious way.
It is important to follow the science and be objective, but it is really tricky to work out if this drug is useful, when, and for which types of patient.
This trial should really have examined some critical indicators e.g. O2 saturation etc if they want to see if IVM had some clinical benefit over the week. Especially with such low sample sizes.
Dr. Tarek Alam points out the importance of early treatment:
At the very least, using them in the first few days of being positive with or without symptoms may save the admissions of those 20% who suffer and the unnecessary deaths on ventilators.
[-] TotesMessenger | 1 points
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[-] TrumpLyftAlles | 2 points | Oct 24 2020 07:18:09
As far as I can tell, this trial isn't registered anywhere. It seems like a plain old failure. :(
From the PDF:
It was an open label randomized control trial which was done on COVID-19 patients proven by RT- PCR fulfilling the criteria (mild severity).
Inclusion Criteria:
All patients diagnosed with COVID-19 infection
with positive reverse transcriptase RT-PCR test,
who were willing to participate in this study
Patients having age of 18-75 years
Patients of both genders male and female
Patients who had mild symptoms of Corona
virus disease and RT- PCR positive for SARSCov-2
* Ability to take oral medication and were willing
to adhere to the drug intake regimen
Exclusion Criteria:
Known severe allergic reactions to Ivermectin
Pregnancy or breastfeeding
Severe symptoms likely attributed to Cytokine
Release Storm
Malignant diseases
Chronic kidney disease
Cirrhosis liver with Child class B or C
Ivermectin Prescribing protocol: Patients were prescribed Ivermectin 12mg stat and then 12 mg after 12 hours and 12mg after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue.
On follow up at day 7, patients were stratified as asymptomatic and symptomatic. Amongst the case group, out of 25 patients, 16(64%) patients were asymptomatic and rest of the 9(36%) patients was asymptomatic. In control group, out of 25 patients, 15(60%) patients were asymptomatic and rest of the 10(40%) patients was asymptomatic. p-value (0. 500) statistically there is no significant difference between case group who were given ivermectin along with symptomatic treatment and control group who were only given symptomatic treatment without ivermectin, being asymptomatic on day 7 at follow up. p-value (0. 500)
This is the only weakness of the study: (subjectively) asymptomatic and symptomatic. It wasn't blinded. Why didn't they do a PCR or something else that's more objective?
Discussing about the comorbidities, out of all these 50 patients, there were 20(40%) patients who had diabetes mellitus, 11(22%) in case group and 9(18%) in control group. Hypertension was seen in 13(26%) patients, 7(14%) in case group and 6(12%) in control group. There were 6(12%) obese patients, 2(%4) in case group and in 4 (8%) in control group. Cardiovascular disease was observed in 4 (8%) patients and each group had 2(4%) patients. There were 15(30%) patients who were active smokers, 9 (18%) in case group and 6(12%) in control group. There was no patient with chronic lung disease in our study (Table-3)
The ivermectin group had more diabetes and more smokers but less obesity. The differences weren't huge.
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