Dear @Dong Nguyen-Van

PICOTS framework may be followed for a Randomized Control Trial (RCT) to know the impact/effectiveness of Ivermectin in mild to moderate Covid-19 patients.

P= Patients (e.g. COVID-19 patients)

I= Ivermectin Drug

C= Control group (e.g. without Ivermectine or different drug)

O= Outcome (effectiveness but think about clinical outcomes what you want to measure)

T= Time (e.g. duration of trial)

S= Settings (e.g. context or location of study)

To design a high quality research. You should keep few things in mind:

1.Duration of study: a longer duration means a better study wid gud outcome

2.Patient or case selection or Sample size

3.Control group: with and without Ivermectin to reduce bias in the study

4.powerful statistical analysis tools to compare the outcome or results

5.Results: should be compared and matched between the two groups.

6.Finally, Conclusion or outcome

Article Statistical design of Phase II/III clinical trials for testi...

Thank you so much for your help. I will have some updates for you after finish my assignment.

This chapter in the Cochrane handbook highlights the common causes of bias in studies. Understanding these will help you to avoid them and produce better quality research.

https://handbook-5-1.cochrane.org/chapter_8/8_assessing_risk_of_bias_in_included_studies.htm

Dear Dr.

Fist to all you must do a double blind trial with placebo control cases. If you don't investigate in that way your results would be misleading.

Yes, I also agree with @Roberto Gabriel Albin-Cano about double blind trial

Effectiveness of Ivermectin in mild to moderate Covid-19 patients: a Double-Blinded, Randomized Controlled Trial

Background:

Ivermectin is a FDA-approved antiparasitic drug for: onchocerciasis, helminthiases, and scabies.

In vivo: anti-viral effect with dengue, Zika, HIV, yellow fever, and SARS-CoV 2

IVM have lower cost compared to other drugs (Remdesivir 550USD/unit 5mg/ml; IVM 29 USD/20 tablets 3mg)

Used by at least 39 countries

Not approved by FDA, WHO for Covid-19

Limitations:

The sample size of most of the trials was small (< 100 people).

Various doses and schedules of ivermectin.

Some of the randomized controlled trials were open-label studies

Patients received various concomitant medications.

The severity of COVID-19 in the study participants was not always well described.

The study outcome measures were not always clearly defined.

PICO: Population

Inclusion criteria:

• Inpatient, 18 or above years old

• RT-PCR positive with Sars-Cov-2

• Mild to moderate symptoms

• Within 7 days after onset

• Consent form

Exclusion criteria:

• Pregnant/Breastfeeding

• In another clinical trial

• Used Ivermectin before randomizing

• Allergy with Ivermectin

• Contraindication to Ivermectin (eg. ClCr5 times ULN, Long QTc, Heart failure, recently MI)

• Asymptomatic patient or severe/critical disease

Intervention: Ivermectin 0.6mg/kg/day in 5 days + Standard care

Comparison: Placebo in 5 days + Standard care

Outcome:

Primary outcome:

Number of patients progress to severe stage

Secondary outcome:

Number of patients have clinical response after 5 days, 10 days

Day from randomizing to clinical response

Mortality

Length of hospital stay

Adverse effects/suspected adverse effects

Hypotheses:

H0: Ivermectin does not reduce the proportion of mild and moderate Covid-19 patients who progress to severe stage.

H1: Ivermectin reduces the proportion of mild and moderate Covid-19 patients who progress to severe stage.

Sample size:

Test target

Case control by placebo superior test

Main endpoint

The proportion of patient who progress to severe stage

Null hypothesis H0

P1(Placebo)=P2(Ivermectin)

Alternative hypothesis H1

P1(Placebo) ≠ P2(Ivermectin)

Test Statistics

t-test

Type I

α=0.05 (two tail)

Type II (Power)

β=0.2 (1-β=0.8)

Effect size d

10%

P1

P1=11.1% (P2=7.5%)

Allocation rate

1:1

Drop out rate (p)

5%

📷 >> 1212 per group