There are already 16 trials for coronavirus vaccines and treatments authorized in the country: one by one, which ones are

Vanesa Lopez

09/26/2020 - 17:06

• Clarín.com

• Society

This week, the start for next month of the Janssen laboratory trial was announced, and thus there would already be three clinical studies of a coronavirus vaccine that will be carried out in the country.

But in addition to the vaccine, studies are underway for different treatments: in total there are already 16 locally authorized clinical trials that seek to investigate the effects of different drugs, in addition to the global Solidarity study in which Argentina participates.

Some are ongoing, others are about to start, and some are even finished. 

The protocols to test all these drugs have already been authorized by the National Administration of Medicines, Food and Medical Technology (ANMAT), which published the list on its website, which will be updated if new research is authorized.

So far, the investigation of three vaccines, 12 drugs and the application of equine serum has been authorized.

One by one, what are they and what peculiarities do they have.

RNA vaccine

The Pfizer and BioNTech vaccine was developed with a

called messenger RNA (mRNA).

The phase IIb / III clinical study began in August at the Military Hospital, led by the infectologist Fernando Polack.

4,500 volunteers between 18 and 85 years old participate.

The investigation continues and, at the moment, no results have been released.

Inactivated vaccine

It is an alliance of the Argentine laboratory Elea-Phoenix with the Chinese Sinopharm.

In this

, the virus is killed and is adjuvanted with a chemical compound that increases the immune response.

The phase III clinical trial began in Argentina last week and seeks to recruit 3,000 healthy volunteers aged 18 to 85 years.

Those interested can register on the website of the Fundación Hupedes.

Vaccine based on an Ad26 vector

Immunization could occur

, instead of two, as with the other vaccines.

This Wednesday, Janssen - part of the Johnson & Johnson group - announced the launch of phase III of the clinical trial in the United States, which will have 60,000 volunteers globally.

will also be recruited 

, Brazil, Chile, Colombia, Mexico, Peru, and South Africa.

In our country, the research will be led by the Center for Infectious Studies, an entity created by the infectologist Daniel Stamboulian.

From the laboratory they indicated that they estimate to begin the recruitment of volunteers - which will include those over 60 years old - next month. 

Ivermectin is used to control parasitosis.

Ivermectin

It is an antiparasitic molecule that is used in human health to control parasites.

To evaluate its effect against COVID-19 in mild stages, a phase II clinical trial was carried out in the CEMIC, Muñiz and Cuenca Alta de Cañuelas hospitals, with 45 volunteers.

"The finding was that ivermectin 

in those patients who start treatment early," says Eduardo Spitzer, scientific director of Elea-Phoenix. 

Sarilumab

It is approved in several countries, including Argentina, for the treatment of adult patients with rheumatoid arthritis.

To evaluate it in covid-19, in a phase III clinical study, 420 volunteers participated in 12 countries, among which Argentina was included.

It has already concluded globally, the results were published in early September, and it

.

RIPK protein inhibitor

The DNL758 molecule seeks to

to the viral infection generated by SARS-CoV-2 and limit the potential damage that results from excessive inflammation.

The phase Ib clinical study

, with the participation of five countries: Argentina, Brazil, Chile, Mexico and Russia.

In total, 67 patients will be included and it is expected to end in November.

TAF / FTC (Emtricitabine / Tenofovir alafenamide)

"This is the

clinical trial (compared to placebo)

" says the coordinator in Argentina, Waldo Belloso.

The Argentine Society of Infectious Diseases (SADI) is a sponsor.

It is being carried out in 15 centers of the City, Buenos Aires, Rosario, Córdoba, Mar del Plata, La Plata, San Juan, La Rioja, Mendoza and Tucumán.

The participants are health workers exposed to COVID-19 and seek to demonstrate whether the drug helps 

Pirovano Hospital participates in the ruxolitinib clinical trial.

Photo Andrés D'Elia.

Ruxolitinib

It is a drug for oral administration, approved for the treatment of myelofibrosis and polycythemia vera.

Now they are testing it in a phase III clinical trial to treat the

resulting from COVID-19 infection.

The clinical trial is being carried out at the Pirovano Hospital, the Durand Hospital, and the Zabala Clinic.

Some 27 Argentines started treatment, out of a total of 432 patients in the world.

Sirukumab

“In Argentina we have not started yet, we are waiting for the green light from the sponsor.

It is being done in the United States, ”says Marcelo Casas, the study's principal investigator.

Sirukumab is an anti-IL-6 monoclonal antibody.

The clinical study will be carried out in patients hospitalized for COVID pneumonia, who will receive

.

Then, the percentages of improvement and mortality will be evaluated.

Therapy rooms of the Sanatorio Güemes.

Photo Luciano Thieberger.

DFV890

DFV890 is a potent inhibitor of NLRP3, a protein from the inflammasome family, that seeks to

.

In a phase II clinical trial, it will be administered orally.

There are 120 participants in recruitment around the world,

.

They are patients with covid-19 and pneumonia with compromised respiratory function.

It will be held at the Güemes and Modelo de Quilmes sanatoriums.

Baricitinib

It is an immunomodulatory drug, administered orally, used to treat rheumatoid arthritis.

To evaluate its application in patients with COVID-19 infection, a randomized, double-blind, and placebo-controlled Phase III study is currently being conducted in Argentina.

It is ongoing in

the country.

Acalabrutinib

The phase II study has been completed in Argentina.

"We are waiting to see what results it gave," says Dr. Casas, who is also participating in this clinical trial.

“In immunomodulators will be the key to success.

If you already have a treatment, no matter how hard you are, you take the pill and at least you don't get inflamed.

Because

.

It is not the virus itself, but the body's response to the virus, "he says. 

ANMAT authorized 16 clinical trials in the country.

Otilimab

It is a medicine for rheumatoid arthritis, which is being tested in patients suffering from pneumonia caused by covid-19.

The ANMAT approved in our country a randomized, double-blind, placebo-controlled study, in which the safety and efficacy of

in patients with severe lung disease related to the coronavirus

is evaluated

. 

Budesonide

The study is called TACTIC COVID.

Try to find out if moderate doses of inhaled budesonide can prevent the worsening of patients with COVID-19 pneumonia.

The phase III trial has already begun in our country.

It is planned to include

, with the intervention of public and private centers.

Mild to moderate patients with no comorbidities or previous use of inhaled steroids are included.

Dapagliflozin

The ANMAT authorized a

in Argentina to

evaluate the efficacy and safety of dapaglifozin in respiratory failure in patients with covid-19.

According to the official provision, the investigation will be carried out at the Güemes Sanatorium and will consist of administering 30 doses of this drug –which comes in tablets- to each participant.

Laboratory tests for the development of equine serum.

Photo Immunova.

Equine serum 

Treatment with hyperimmune equine serum - which consists of inoculating a horse, extracting the plasma, purifying it, and administering it to patients - is still under investigation.

of the phase II / III clinical study

, which is being carried out in 20 hospitals and clinics in the City, Buenos Aires province, Neuquén and Tucumán.

Look also

A new study of the coronavirus vaccine is dated in Argentina and there are already three trials

One by one, the treatments against the coronavirus that are tested in Argentina