PESHAWAR: According to report submitted recently to the Drug Regulatory Authority of Pakistan (DRAP), the convalescent plasma immunisation has saved 92 per cent, critical COVID-19 patients, from being put on ventilators and 80 per cent others have shown prompt recovery after 48 hours. The report updated regarding the usefulness of plasma for coronavirus patients during the ongoing pandemic in the country.
It said that that the patients would have gone to a ventilator as they were unresponsive to every supportive treatment. They were unable to maintain their oxygen saturation in their blood despite every treatment, it added.
The report has recommended that convalescent plasma (CP) should be given to moderate and severe patients. Patients receiving CP within the first five days of admission showed good results than those, who got it after seven days, or those, who were already on the ventilator.
It could be life-saving when given early before the massive tissue damage occurred in the affected patients, it added.
Therapy shows good results in the first five days of admission
Keeping in view the rapid mortality due to COVID-19, the Drug Regulatory Authority of Pakistan (DRAP) approved convalescent plasma investigational use and appointed Dr Tahir Shamsi, dean and chairman of National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD & BMT) Karachi, as principal investigator along with Prof Javed Akram and Prof Bikha Ram Deverajani, as co-principal investigators.
The clinical trial was conducted at Hayatabad Medical Complex (HMC) Peshawar under the supervision of Prof Shahtaj Khan Masood, at University of Health Sciences Lahore under Prof Faridoon, at Liaquat University of Medical and Health Sciences (LUMHS) Jamshoro under Prof Ikram Ujjan, Rawalpindi Medical College (RMU) Rawalpindi under Dr Lubna Meraj and NIBD Karachi under the supervision of Dr Arshi Naz.
Five centres received over 400 plasma donations from the COVID-19 patients, who had recovered. The plasma was extracted after fulfilment of the laid down criteria.
An 8-page report regarding convalescent plasma (CP) therapy has been submitted to DRAP, which is likely to make it public within the next few weeks. It says that 357 patients were categorised according to severity of the disease and transfused CP after assessing the eligibility criteria for recipients as per trial protocol.
The recipients aged between 29 to 92 years, included 77.8 per cent males and 22.2 per cent females.
CP was utilised during COVID-19 pandemic in the country as a potential therapy as the trial was meant for appraisal of CP transfusion for its safety and usefulness in coronavirus.
The report said that the US Food and Drug Administration issued an emergency use authorisation (EUA) for investigational CP for treatment of COVID-19 in hospitalised patients. So far, more than 100,000 patients have received CP and over 2,500 hospitals and thousands of doctors have been involved in using plasma in the US.
The patients were categorised as moderately severe, severe, and critical. Primary endpoints included the ability of CP to halt disease progression leading to invasive ventilation and improvement in clinical status and change in the category of disease severity.
The plasma was given to hospitalised patients; either alone or in conjunction with other experimental drugs. All the patients having COVID-19 PCR positive were hospitalised prior to receiving CP.
The patients were categorised according to the approved protocol in three categories, including moderately severe, severe and critical. Of the total, 30 per cent of patients were in the moderately severe category, 68 per cent in severe and two per cent were in the critical category. The plasma was transfused alone into 72 per cent, in conjunction with tocilizumab into 10 per cent and with Remdesivir into 18 per cent with no severe adverse reaction.
The report said that in 80 per cent recipients, oxygen saturation improved from 80 per cent to 95 per cent within 72 hours. CP saved 92 per cent recipients from going on ventilators and 80 per cent improved after 48 hours.
According to the report, 20 per cent patients expired due to comorbidities, including cardiac arrest in 8 per cent, multiorgan failure secondary to cytokine storm in eight per cent and ventilator-associated complications in four per cent.
It says that CP can be allowed under emergency use authorisation in Pakistan as there is no approved treatment available so far. It can be given as an initial treatment to COVID-19 patients within 3-5 days of onset of symptoms.