Aside: According to some tweets I read today, it is illegal to prescribe ivermectin in Brazil. MDs are giving it to themselves and their families, but they face liability and licensing trouble if they prescribe it. This study could change that. Too bad it won't be done before December.
Official title: Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)
Brief Summary:
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.
The study has 5 arms, 4 of them trying different doses of imvermectin:
1) Standard treatment (no ivermectin)
2) One dose at 100mcg/kg
3) Two doses at 100mcg/kg, the second 72 hours after the first
4) One dose at 200mcg/kg
5) Two doses at 200mcg/kg, the second 72 hours after the first
Primary outcome measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab [Time Frame: 7 days]
There are 7 secondary outcome measures: viral load; serum lymphocyte counts, AST/ALT, D-dimer, CPK, LDH; time to clinical improvement (normal temperature, respiration, oxygen saturation, no coughing)
Ages: 18+
The inclusion criteria call for acute symptoms, e.g. this is for the sickets patients (I guess?)
Thoughts:
It could be genuinely useful, to establish a dose-response for ivermectin and COVID-19. However, the doses are too low! The standard low dose is 200mcg/kg. Two of the four ivermectin arms are testing half of that. This would make sense if ivermectin cost $1400/dose, but it's dirt cheap, so the cost difference between 100mcg/kg and 200mcg/kg is negligible.
[-] TrumpLyftAlles | 1 points | Jun 16 2020 18:41:32
Aside: According to some tweets I read today, it is illegal to prescribe ivermectin in Brazil. MDs are giving it to themselves and their families, but they face liability and licensing trouble if they prescribe it. This study could change that. Too bad it won't be done before December.
Official title: Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)
Brief Summary:
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.
This is a randomized controlled study with N=64.
Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary completion date: 2020-12-01
The study has 5 arms, 4 of them trying different doses of imvermectin:
1) Standard treatment (no ivermectin)
2) One dose at 100mcg/kg
3) Two doses at 100mcg/kg, the second 72 hours after the first
4) One dose at 200mcg/kg
5) Two doses at 200mcg/kg, the second 72 hours after the first
Primary outcome measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab [Time Frame: 7 days]
There are 7 secondary outcome measures: viral load; serum lymphocyte counts, AST/ALT, D-dimer, CPK, LDH; time to clinical improvement (normal temperature, respiration, oxygen saturation, no coughing)
Ages: 18+
The inclusion criteria call for acute symptoms, e.g. this is for the sickets patients (I guess?)
Thoughts:
It could be genuinely useful, to establish a dose-response for ivermectin and COVID-19. However, the doses are too low! The standard low dose is 200mcg/kg. Two of the four ivermectin arms are testing half of that. This would make sense if ivermectin cost $1400/dose, but it's dirt cheap, so the cost difference between 100mcg/kg and 200mcg/kg is negligible.
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