Triple drug therapy with Hydroxychloroquine, Oseltamivir and Azithromycin shows promise for treatment of COVID-19 infection

Print

Initial results of PROTECT study involving 525 patients released
Triple drug therapy with Hydroxychloroquine,
Oseltamivir and Azithromycin shows
promise for treatment of COVID-19 infection
Prof. Javed Akram VC UHS is the Principal Investigator
of the study which will  enroll over nine thousand patients
at over a dozen Centers all over Pakistan

LAHORE: Initial result of Pakistan Randomized and Observational Trial to Evaluate Coronavirus treatment (PROTECT) study related to five hundred twenty five patients enrolled till July 5th 2020 were released at a meeting held at University of Health Sciences Lahore on July 20,2020. The meeting was chaired by Governor of Punjab Chaudhry Mohammad Sarwar while Minister of Higher Education Punjab Mr. Yasir Humayun and Chairman Board of Governors of UHS Mr. Justice Tussadaq Hussain Jillani were also present on this occasion. Investigators participating in the study from some other centers were also present.

Initial findings which were presented by Prof. Javed Akram showed that the triple therapy which includes Hydroxychloroquine, Oseltamivir and Azithromycin had showed promise for the treatment of COVID-19 infection hence it has been decided to continue this randomized controlled trial further. As per their findings 85.9% of patients became negative at the end of twelve days with the use of this triple therapy. During the trial so far only four deaths have occurred but there was no death in the triple therapy group. Thus this trial has established the safety of treatment regimens with minimum adverse drug reactions. It is essential to continue more recruitment. As a result of this study, Prof. Javed Akram said, we have also achieved an excellent teamwork across hospitals representing high quality evidence. It also enabled us to have successful execution of Good Clinical Practice framework while about fifty clinical researchers were also being trained as a part of this project. The Trial protocol of the study he further stated was published in Trialjournal.biomedcentral.com. The Trial is also registered with Clinicaltrials.gov with ID No. NCTO4338698. Seven universities from all over Pakistan are participating in this study which will enroll over nine thousand patients and so far thirty million rupees have been spent which were collected by the UHS through its own resources and donations, financial assistance from our friends from the pharmaceutical industry.

Speaking about the common misperceptions of COVID-19, Prof. Javed Akram said that unfortunately many thought that it was no more than a seasonal flue. However, level of public health preparedness was adequate. Some people felt that it was sensitive to hot and dry weather hence as soon as the weather is hot, it will go away, traditional medicines also offer cure. It was generally felt that only elderly people are vulnerable to COVID19 infection but we have seen that many of these misconceptions were not true and it did affect a large number of patients in the younger age group as well.

Giving details of the Trial, Prof. Javed Akram said that we planned to evaluate Hydroxychloroquine alone and in various combinations with other drugs. Hence a multicenter, multiarm, adaptive, randomized control drug trial was conceived to enroll newly diagnosed patients. The project was formally inaugurated by the Governor of Punjab a few months ago. University of Health Sciences, he further stated, has been building partnership and linkages, developing scientific framework, meeting all the statutory requirements like approval of the study from National Bioethics Committee (NBC) and Drug Regulatory Authority of Pakistan (DRAP). We also undertook training of researchers at our partnering sites. Primary patient outcome of the study included turning test negative for COVID-19 on qRT-PCR besides clinical outcome of improvement of two points on a seven category ordinal scale on day seven of follow up.

The inclusion criteria for the study was confirmed COVID19 infection by a positive test result, either gender, above the age of eighteen years. The symptoms included fever, dry cough, and difficulty to breathe. Those patients with confirmed absence of COVID-19 infection, those with chronic conditions such as heart disease, liver and kidney failure or those presenting with respiratory distress, pregnancy or currently lactating, immunocompromise or those suffering from systemic diseases, those on antiviral therapy besides those with history of allergy to any of the drugs being administered in the study were excluded.

Until July 5, a total of five hundred twenty five patients were enrolled in the study during a period of three months. It included three hundred twenty (61.1%) male and two hundred four (38.9%) female. Majority of the patients enrolled 82.9% were below the age of sixty years. There were eight study arms using Hydroxychloroquine alone and with some other drugs in different combinations. Almost 85.9% of patients became negative with the triple drug therapy after twelve days while recovery rate with other combinations, other groups also varied.

Prof. Khalid Masood Gondal Vice Chancellor of King Edward Medical University speaking on the occasion said that KEMU/Mayo Hospital has so far contributed one hundred twenty patients to this study and more enrollments is going on. COVID-19 was a challenge but it also provided some opportunities. Prof. Asad Aslam Chief Executive of Mayo Hospital is also present here and we faced the major brunt and rush of patients. Fortunately now we have come out of the crisis and currently our bed occupancy due to covid19 is between 10-15%. Maximum number of patients were managed at Mayo Hospital Lahore. As a university we are engaged in producing Knowledge and Research. We also established the Telemedicine Department besides Corona Helpdesk which has been of great help to the patients. We are working as a team all the three universities in Lahore are collaborating with each other. Members of the medical profession, he further stated, has given lot of sacrifices during this COVID19 pandemic. He appreciated the announcement of Civil Award for late Prof. Mustafa Kamal Pasha Vice Chancellor of Nishtar Medical University who passed away on July 15th due to COVID19 infection and Government’s announcement has encouraged the healthcare professionals to keep on fighting this virus and manage the infected patients.

Mr. Yasir Humayun Minister for Higher Education Punjab congratulated the research team headed by Prof. Javed Akram for producing evidenced based data. Research, he opined, was an important part of functioning of the universities. Medical profession in Pakistan is well equipped to be the leaders in research as well provided we encourage and promote research culture. All appointments in the medical universities, he further stated, was now being made on merit which has promoted academic environment.

Governor of Punjab Chaudhry Mohammad Sarwar in his address congratulated the UHS team for presenting the interim result of the study. He paid rich tributes to late Prof. Mustafa Kamal Pasha Vice Chancellor of Nishtar Medical University and to recognize his devoted services, we have recommended his name for a Civil Award. We have so far successfully checked the spread of CORIV19 infection but still there are three major challenges which include following SOPs, the forthcoming Eid ul Azha and the Moharram. We hope people will follow the SOPs which will help us to defeat the Corona. All the Vice Chancellors of medical universities, he further stated have shown leadership qualities they have done wonders. He assured them that they will take care of their autonomy and make sure that all their issues are resolved on priority basis. There will be no hurdles. He also thanked the donors who provided an amount of five hundred twenty five crore rupees to help us provide ration, drugs, PPEs to those affected with Corona virus and the healthcare professionals. He agreed that we need to improve our primary healthcare and give GPs, Family Physicians due importance in healthcare delivery system. He also thanked Dr. Shehla Akram who along with my wife, the Governor said, had established the Pink Corona Helpdesk at UHS so that female patients could seek medical advice regarding COVID-19 infection.

Earlier Prof. Azizur Rehman Chairman of the NDSMB which was established to observe any Adverse Drug Reactions during the study to ensure patient safety in his brief address stated that none of the treatment arm of the study showed any significant adverse drug reactions. Mr. Nasrullah Malik a noted journalist who also got infected with COVID19 infection and was successfully treated also briefly spoke on the occasion and narrated his ordeal during his sickness. He thanked Prof. Javed Akram and their team for taking care of him which ensured his recovery. Dr. Somia Iqtidar General Secretary of Pakistan Society of Internal Medicine which is collaborating in this study presented the vote of thanks and thanked all the investigators, collaborating institutions for their valuable help and assistance in this study.

The institutions which are participating in the study include the following:

  • University of Health Sciences Lahore
  • King Edward Medical University- Mayo Hospital Lahore
  • Fatima Jinnah Medical University Lahore.
  • Shaheed Zulfiqar Ali Bhutto Medical University- Pakistan Institute of Medical Sciences Islamabad
  • Rawalpindi Medical University
  • Faisalabad Medical University
  • Lahore General Hospital Lahore
  • Sargodha Medical College
  • Nawaz Sharif Medical College Gujrat
  • Gujranwala Medical College
  • Khyber Teaching Hospital, Peshawar
  • Akram Medical Complex Lahore.
© Professional Medical Publications. All rights reserved.