Molnupiravir shows promise for most COVID-19 patients

Research scientists and pharmaceutical companies burn the midnight oil enduring sleepless nights, toiling to come up with conclusive treatments meant to put to rest the menacing COVID-19 pandemic.
Proving persistant in being resistant to available medications, the Severe Acute Respiratory Syndrome SARS-COV 2 , the causative agent of COVID-19 mutated into various strains namely the Alpha variant detected in the UK, Beta variant in South Africa , Gamma variant in Brazil and Delta variant in India. The Delta variant, has turned out to be the most virulent for it spreads more and faster than the rest.
When the disease was first discovered in China, many treatments where used given the Asian tiger had once encountered SARS-CoV. Among them were chloroquine, an anti-malarial.
As the disease spread from China to neighboring countries such as South Korea, the neighbour administered an antiretroviral Kaletra as well as chloroquine.
Both compounds or medicines were deemed to be unsafe for patients.
In an attempt to save lives of those with severe and moderate illnesses, other drugs were dispensed. These included Lopinavir, Ritonavir as protease inhibitors meaning they blocked the COVID-19 spikes from attaching to the individual’s ribonucleic acid (RNA).
Scientists and medical professionals also had to revisit Remdesivir which was successful in the management of Ebola Virus patients. With Remdesivir showing promises in severely ill patients, researchers found this new entrant being easily accepted as it is a pill.
With the search on-going, a new kid on the block, rather in its fetal stages as it is still an investigational shows a lot of promises
Addressing a ‘New and Emerging Therapeutic Options for COVID-19 with focus on Molnupiravir’ Hetero Pharmaceuticals organised webinar on Thursday, an American Infectious Diseases expert Dr Robert Grossberg said repurposing exisiting drugs is the approach taken to fight the pandemic while looking for a clear-cut treatment option. Molnupiravir is among the list repurposing drugs. “Repurposing exisiting drugs based on similarity of disease mechanisms overcomes sustained high failure rates, time and costs involved in the research and development of novel compounds, and is the rational approach in the current pandemic. Repurposed drugs have the advantage of less development costs and time because if their previously available pharmacokinetic, toxicology and safety data,” he said.
He also said: “To date there is no definitely effective therapy for COVID-19 patients. Therefore, the key management for of COVID-19 patients include a variety of supportive measures including early diagnosis.”
Molnupiravir is an investigational drug that inhibits the replication of multiple RNA viruses including SARS-COV 2 , the causative agent of COVID-19. “And Molnupiravir has been shown to be active in several models of SARS-COV 2 including prophylaxis, treatment and prevention of transmission as well as SARS-COV-1 and MERS,” Dr Grossbert said adding, “This drug can be given with or without food which is of course an attractive feature for an oral drug.”
Preclinical studies have been done with clinical studies still underway. The studies are being done on patients with mild to moderate illness. The oral drug probably will not work on severely ill COVID-19 patients.
“So preclinical studies reveal a broad spectrum of antiviral activity against coronaviruses including SARS-CoV 2 with high barrier to resistance because of this two step method of action. Molnupiravir was also highly effective when administered prophylactically, and therapeutically in mouse models of SARS-CoV 2 and MERS-CoV. A therapeutic dose of 5mg/kg was completely effective in blocking SARS-CoV 2 transmission from infected animals that shed virus to cohoused uninfected animals. And doses of 150 and 500mg/kg were effective in significantly reducing lung viral loads and in improving pulmonary function. Additional safety data has emerged. Molnupirabir was well tolerated at doses of 50 to 800mg. administered twice a day for 5, 5 days and at single doses of up to 1 600 mg. The most frequently observed adverse events was headache in the single ascending dose part and diarrhea in the multiple ascending dose part. Clinically significant findings or dose related trends in clinical laboratory, vital signs, electrocardiography, taken with the tolerabilty findinga indicate that molnupiravir was generally safe at the dose levels and duration tested. In conclusion for the phase one trial, Molnupiravir was safe and well tolerated. A dose of 800mg twice daily for five days was recommended for Phase II evaluation,” said Dr Grossberg.
Dr Grossberg said Phase II is a randomised, placebo controlled, double-blind, multi-sire study evaluating the efficacy, safety anf pharmacokinetics of molnupiravir with non-hospitalised participants of at least 18 years of age. Participants should have laboratory confirmed COVID-19 positive results and symptom onset within seven days prior to randomisation.
“We plan to enroll a 1850 participants with mild or moderate COVID-19. They receive 200mg, 400mg, 800mg or placebo twice daily for five days. The primary efficacy objective is to evaluate efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalised and or die during period from.randomisation through Day 29,” he said.
He also revealed there are interim clinical results from Phase III Clinical Trial of Molnupiravir conducted in India where patients were randomised to receive either molnupiravir capsules 80pmg (4 x 200mg) every 12 hours twice daily for five days alomg with standard care or control arm to receive standard of care alone.
“We can see that compared to the control arm, 63 percent versus 22 percent had early clinical improvement at day five. Median time to clinia improvement was as early as eight days in Molnupiravir group compared to 12 days in the Standard of Care alone group.
Early SARS CoV 2 RT-PCR negativity in “Molnupiravir group compared to standard of care as you can see a reduction from 77 percent being PCR Positive at Day 5 versus 26 percent. Suggesting probably shortened duration of illness and shortened duration of infectivity. Fewer hospital admissions in Molnupiravir group compared to SOC alone. “No mortality in either group. All adverse events were non serious, mild in severity and non led to drug discontinuation. Most common adverse events reported were nausea, diarrhoea and headache which were resolved completely,” he said.
He said they are currently enrolling participants for an Antiviral prophylaxis Molnupiravir study dubbed MOVe-Ahead trial in the Bronx in New York. The study is a randomised, double blinded trial for prophylaxis of household contacts.
With most cases in Zimbabwe and other Low and Middle Income Countries have more moderate or mild COVID-19 cases, Molnupiravir could do the trick reducing the duration of illness and infectivity.

Research scientists and pharmaceutical companies burn the midnight oil enduring sleepless nights toiling to come up with conclusive treatments meant to put to rest the menacing COVID-19 pandemic.
Proving persistant in being resistant to available medications, the Severe Acute Respiratory Syndrome SARS-COV 2 , the causative agent of COVID-19 mutated into various strains namely the Alpha variant detected in the UK, Beta variant in South Africa , Gamma variant in Brazil and Delta variant in India. The Delta variant, has turned out to be the most virulent for it spreads more and faster than the rest.
When the disease was first discovered in China, many treatments where used given the Asian tiger had once encountered SARS-CoV. Among them were chloroquine, an anti-malarial.
As the disease spread from China to neighboring countries such as South Korea, the neighbour administered an antiretroviral Kaletra as well as chloroquine.
Both compounds or medicines were deemed to be unsafe for patients.
In an attempt to save lives of those with severe and moderate illnesses, other drugs were dispensed. These included Lopinavir, Ritonavir as protease inhibitors meaning they blocked the COVID-19 spikes from attaching to the individual’s ribonucleic acid (RNA).
Scientists and medical professionals also had to revisit Remdesivir which was successful in the management of Ebola Virus patients. With Remdesivir showing promises in severely ill patients, researchers found this new entrant being easily accepted as it is a pill.
With the search on-going, a new kid on the block, rather in its fetal stages as it is still an investigational shows a lot of promises
Addressing a ‘New and Emerging Therapeutic Options for COVID-19 with focus on Molnupiravir’ Hetero Pharmaceuticals organised webinar on Thursday, an American Infectious Diseases expert Dr Robert Grossbert said repurposing exisiting drugs is the approach taken to fight the pandemic while looking for a clear-cut treatment option. Molnupiravir is among the list repurposing drugs. “Repurposing exisiting drugs based on similarity of disease mechanisms overcomes sustained high failure rates, time and costs involved in the research and development of novel compounds, and is the rational approach in the current pandemic. Repurposed drugs have the advantage of less development costs and time because if their previously available pharmacokinetic, toxicology and safety data,” he said.
He also said: “To date there is no definitely effective therapy for COVID-19 patients. Therefore, the key management for of COVID-19 patients include a variety of supportive measures including early diagnosis.”
Molnupiravir is an investigational drug that inhibits the replication of multiple RNA viruses including SARS-COV 2 , the causative agent of COVID-19. “And Molnupiravir has been shown to be active in several models of SARS-COV 2 including prophylaxis, treatment and prevention of transmission as well as SARS-COV-1 and MERS,” Dr Grossbert said adding, “This drug can be given with or without food which is of course an attractive feature for an oral drug.”
Peeclinical studies have been done with clinical studies still underway. The studies are being done on patients with mild to moderate illness. The oral drug probably will not work on severely ill COVID-19 patients.
” So preclinical studies reveal a broad spectrum of antiviral activity against coronaviruses including SARS-CoV 2 with high barrier to resistance because of this two step method of action. Molnupiravir was also highly effective when administered prophylactically, and therapeutically in mouse models of SARS-CoV 2 and MERS-CoV. A therapeutic dose of 5mg/kg was completely effective in blocking SARS-CoV 2 transmission from infected animals that shed virus to cohoused uninfected animals. And doses of 150 and 500mg/kg were effective in significantly reducing lung viral loads and in improving pulmonary function. Additional safety data has emerged. Molnupirabir was well tolerated at doses of 50 to 800mg. administered twice a day for 5, 5 days and at single doses of up to 1 600 mg. The most frequently observed adverse events was headache in the single ascending dose part and diarrhea in the multiple ascending dose part. Clinically significant findings or dose related trends in clinical laboratory, vital signs, electrocardiography, taken with the tolerabilty findinga indicate that molnupiravir was generally safe at the dose levels and duration tested. In conclusion for the phase one trial, Molnupiravir was safe and well tolerated. A dose of 800mg twice daily for five days was recommended for Phase II evaluation,” said Dr Grossbert.
Dr Grossbert said Phase II is a randomised, placebo controlled, double-blind, multi-sire study evaluating the efficacy, safety anf pharmacokinetics of molnupiravir with non-hospitalised participants of at least 18 years of age. Participants should have laboratory confirmed COVID-19 positive results and symptom onset within seven days prior to randomisation.
“We plan to enroll a 1850 participants with mild or moderate COVID-19. They receive 200mg, 400mg, 800mg or placebo twice daily for five days. The primary efficacy objective is to evaluate efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalised and or die during period from.randomisation through Day 29,” he said.
He also revealed there are interim clinical results from Phase III Clinical Trial of Molnupiravir conducted in India where patients were randomised to receive either molnupiravir capsules 80pmg (4 x 200mg) every 12 hours twice daily for five days alomg with standard care or control arm to receive standard of care alone.
“We can see that compared to the control arm, 63 percent versus 22 percent had early clinical improvement at day five. Median time to clinia improvement was as early as eight days in Molnupiravir group compared to 12 days in the Standard of Care alone group.
Early SARS CoV 2 RT-PCR negativity in “Molnupiravir group compared to standard of care as you can see a reduction from 77 percent being PCR Positive at Day 5 versus 26 percent. Suggesting probably shortened duration of illness and shortened duration of infectivity. Fewer hospital admissions in Molnupiravir group compared to SOC alone. “No mortality in either group. All adverse events were non serious, mild in severity and non led to drug discontinuation. Most common adverse events reported were nausea, diarrhoea and headache which were resolved completely,” he said.
He said they are currently enrolling participants for an Antiviral prophylaxis Molnupiravir study dubbed MOVe-Ahead trial in the Bronx in New York. The study is a randomised, double blinded trial for prophylaxis of household contacts.
With most cases in Zimbabwe and other Low and Middle Income Countries have more moderate or mild COVID-19 cases, Molnupiravir could do the trick reducing the duration of illness and infectivity.

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