CT- scan and MRI centers in Kathmandu6 November, 2020
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There has been no specific antiviral drug proven to be effective for severe corona virus disease 2019 (COVID-19). Remdesivir is one such antiviral drug with inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models. Therefore, this drug is being used to the patients suffering from moderate to severe COVID-19 symptoms, as a part of compassionate use.
On August 19, 2020, the Government of Nepal permitted to use Remdesivir in COVID-19 patients of Nepal only as a study drug. The Ministry of Health and Population (MoHP), Department of Drug Administration (DDA) authorized import and usage of Remdesivir for treatment of COVID-19 as a study drug and delegated authority to Nepal Health Research Council (NHRC) to oversee its use as a study drug. Also, the Department of Drugs Administration has permitted three private companies to import antiviral medication Remdesivir for the treatment of COVID-19. These companies are Yeti Pharma, Synergy Overseas, and Veiovis Lifescience, who have been given permission to import Remdesivir after meeting the required standards.
Recently an interim result published by World Health Organization (WHO) for the Solidarity Therapeutics Trial indicates that Remdesivir and other drugs like hydroxychloroquine, lopinavir/ritonavir, and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients. However, many other published articles suggest that the Remedisivir do have positive outcomes in moderate to severely ill patients. On October 22, the US Food and Drug Administration approved Remdesivir for use in adults and pediatric patients 12 years of age and older and weighing at least 40 kilograms for the treatment of Covid-19 requiring hospitalization.
It is stated that the objective of a clinical study on Remdesivir in Nepal is to evaluate the outcome of Remdesivir use in patients with COVID-19. According to NHRC, interested institutions (medical colleges and other hospitals) for a clinical study on Remdesivir have to collaborate with NHRC or conduct the study independently following National Ethics Guidelines for Health Research in Nepal, including National Guidelines for Strengthening Evidence Generation on COVID-19 in Nepal. With a set up to conduct clinical studies, these institutions can also develop their study protocols for the use of Remdesivir. They need to get approval from their IRC (lnstitutional Research Board) or NHRC's central ERB (Ethics Review Board) before enrolling patients in the study.
Patients can be recruited from all COVID-19 treating hospitals of Nepal, those participating or conducting a clinical study using Remdesivir. The patients with moderate to severe or life-threatening COVID-19 infection, who meet eligibility criteria as noted qualify for the study.
Eligibility Criteria for Remdesivir treatment:
All patients with:
1. Laboratory-confirmed diagnosis of COVID-19 infection with PCR test positive for SARS-CoV-2.
2. Hospitalized patients admitted to an acute care facility for the treatment of COVID-19.
3. Signed informed consent provided by the patient or patient's healthcare proxy.
4. Moderate to severe COVID-19 infection who require to be on oxygen supplementation.
Note: Severe COVID-19 infection is defined by one or more of the following criteria:
1. Shortness of breath (dyspnea)
2. Respiratory frequency > 30/min
3. Blood oxygen saturation (SaO2) 393% on room air
4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2:FiO2) < 300
5. Lung infiltrates increased more than 50% within 24 to 48 hours
1. Not confirmed with PCR test for COVID-19 infection
2. Cases not meeting criteria for moderate or severe COVID-19 infection
3. Any patient with contraindications for receiving Remdesivir.
4. Patient's declination to enroll in the study
Remdesivir is used as intravenous medicine only. The drug first needs to be reconstituted and then diluted into intravenous infusion fluids (Normal Saline) before use. Based on the current evidence and recommendations from authorities, the following patients should receive intravenous Remdesivir:
Note: Remdesivir is not given for mild cases of COVID-19.
According to NHRC, all the report results need to be reported to the center within 24 hours. Besides, any clinical or laboratory-related adverse reactions noted after Remdesivir administration should be recorded and reported to NHRC and DDA. These adverse events may include allergic reactions, increased liver enzymes, diarrhea, rash, kidney impairment, and hypotension. Patients should have been monitored for renal and hepatic function before initiating and during Remdesivir therapy.
In an emergency or the need for information regarding the study questions, the NHRC study team can be contacted. If there are questions regarding product preparation, handling, storage, or administration, pharmacy staff at the hospital or NHRC should be contacted.
Dr. Pradip Gyanwali (9851118098)
Dr. Janak Koirala (98187621.17)
Nepal Health Research Council, Ramshah Path, Kathmandu
Email: [email protected]
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