Ci Gaban Magungunan COVID-19

**COVID-19 miyagun ƙwayoyi ci gaba,** ne na binciken tsari wajen samar da preventative warkewa sayen magani kwayoyi da cewa zai rage tsananin coronavirus cuta 2019 (COVID-19). Daga farkon shekarar 2020 zuwa shekarar 2021, kamfanoni ɗari da yawa na magunguna, kamfanonin fasahar kere kere, ƙungiyoyin bincike na jami'a, da kuma ƙungiyoyin kiwon lafiya suna haɓaka ƴan takarar warkewa don cutar COVID-19 a matakai daban-daban na bincike na asali ko na asibiti (jimillan yan takara 506 a cikin Afrilun shekarar 2021), tare da yuwuwar 419. Magungunan COVID-19 a cikin gwaji na asibiti, har zuwa Afrilu 2021.

Kamar yadda a farkon Maris din shekarar 2020, da World Health Organization (WHO), Turai Magunguna Agency (Ema), Amurka Food and Drug Administration (FDA), kuma gwamnatin kasar Sin da kuma miyagun ƙwayoyi masana'antun sun kasance suna haɗin gwiwa tare da masu bincike na ilimi da masana'antu don haɓaka haɓakar rigakafi, magungunan rigakafi, da hanyoyin kwantar da hankali bayan kamuwa da cuta. Platform Registry Platform na Clinical Trials na WHO ya rubuta karatun asibiti 536 don haɓaka hanyoyin kwantar da hankali bayan kamuwa da cuta don cututtukan COVID-19, tare da kafaffen magungunan rigakafi da yawa don kula da wasu cututtuka a ƙarƙashin binciken asibiti don sake dawowa,

A cikin Maris din shekarar 2020, WHO ta ƙaddamar da " Gwajin SOLIDARITY " a cikin ƙasashe 10, tare da yin rajistar dubunnan mutanen da suka kamu da COVID-19 don tantance tasirin jiyya na mahaɗan rigakafin ƙwayoyin cuta guda huɗu tare da mafi girman alƙawarin inganci.An kafa bita mai ƙarfi, mai tsauri a cikin Afrilu 2020 don bin diddigin ci gaban gwajin asibiti da aka yi rajista don rigakafin COVID-19 da ƴan takarar making an warkewa.

Ci gaban ƙwayoyi tsari ne na matakai da yawa, yawanci yana buƙatar fiye da shekaru biyar don tabbatar da aminci da ingancin sabon fili. Hukumomin gudanarwa na ƙasa da yawa, kamar EMA da FDA, sun amince da hanyoyin don hanzarta gwajin asibiti. A watan Yuni 2021, da yawa yuwuwar hanyoyin warkewar kamuwa da cuta sun kasance a matakin ƙarshe na gwajin ɗan adam - gwaji na asibiti na Phase III-IV Ingantacciyar magani, dacewa ta COVID-19 na iya kaiwa tallace-tallace na shekara-shekara sama da dala biliyan 10, a cewar wani kiyasin Jefferies &amp;amp; Co na baya- bayan nan.

## Fage

Ci gaban ƙwayoyi shi ne tsarin kawo sabon rigakafin cututtuka ko magungunan warkewa zuwa kasuwa da zarar an gano wani sinadarin gubar ta hanyar gano magunguna. Ya haɗa da binciken dakin gwaje-gwaje a kan ƙwayoyin cuta da dabbobi, yin rajista don matsayin tsari, kamar ta hanyar FDA, don sabon magani na bincike don fara gwajin asibiti akan mutane, kuma yana iya haɗawa da matakin samun amincewar tsari tare da sabon aikace-aikacen magani don tallata maganin.Gabaɗayan tsari - daga ra'ayi ta hanyar gwaji na ainihi a cikin dakin gwaje-gwaje zuwa haɓaka gwaji na asibiti, gami da gwaji na Mataki na I-III - zuwa ingantaccen maganin rigakafi ko magani yana ɗaukar fiye da shekaru goma.

Kalmar "bincike na ainihi" an bayyana shi ta hanyar binciken dakin gwaje-gwaje *a cikin vitro* da *in vivo*, yana nuna matakin farko don haɓaka maganin rigakafin rigakafi, maganin rigakafi ko wasu hanyoyin kwantar da hankali bayan kamuwa da cuta, kamar gwaje-gwaje don ƙayyade ingantattun allurai da guba a cikin dabbobi., kafin a ƙaddamar da fili na ɗan takara don aminci da ƙimar inganci a cikin mutane. Don kammala ainihin matakin haɓaka magunguna - sannan a gwada don aminci da inganci a cikin isassun adadin mutanen da suka kamu da COVID-19 (daruruwan zuwa dubbai a ƙasashe daban-daban) - tsari ne mai yuwuwa yana buƙatar shekaru 1-2 don COVID-19 hanyoyin kwantar da hankali, bisa ga rahotanni da yawa a farkon shekarar 2020. Duk da waɗannan ƙoƙarce-ƙoƙarce, yawan nasarar da aka samu ga masu neman magani don samun amincewar ƙa'ida ta ƙarshe ta hanyar tsarin haɓaka magunguna don magance cututtukan da ke yaduwa shine kawai 19%.

Gwajin gwaji na mataki na farko da farko don aminci da allurai na farko a cikin wasu dozin dozin masu lafiya, yayin da gwaji na II - bin nasara a cikin Mataki na I - kimanta tasirin warkewa game da cutar COVID-19 a matakan haɓakar kashi (sakamako dangane da biomarkers ), yayin da kusanci. kimanta yiwuwar illar cutarwar ɗan takarar (ko hanyoyin kwantar da hankali), yawanci a cikin ɗaruruwan mutane. Tsarin gwaji na gama-gari don nazarin Mataki na II na yiwuwar magungunan COVID-19 bazuwar bazuwar, mai sarrafa wuribo , makanta, kuma ana gudanar da shi a shafuka da yawa, yayin da ake tantance ƙarin madaidaicin, ingantattun allurai da saka idanu don illa.

Nasarar nasarar gwaji na Mataki na II don ci gaba zuwa Mataki na III (ga duk cututtuka) kusan kashi 31% ne, kuma ga cututtuka musamman, kusan 43%. Ya danganta da tsawon lokacin sa (ya fi tsayi tsada) - yawanci tsawon watanni da yawa zuwa shekaru biyu - matsakaicin tsayin gwajin Mataki na II yana kashe  (dala 2013, gami da daidaitaccen farashi da na Mataki na I). Nasarar kammala gwajin Mataki na II baya yin hasashen cewa ɗan takara magani zai yi nasara a cikin bincike na Mataki na III.

Gwajin kashi na III na COVID-19 ya ƙunshi ɗaruruwan-zuwa-dubban mahalarta asibiti, da gwada tasirin jiyya don rage tasirin cutar, yayin da ake sa ido kan illolin da ba su da kyau a mafi kyawun kashi, kamar a cikin gwaje-gwajen Solidarity da Gano na ƙasa da ƙasa.

## 'Yan takara

Dangane da wata majiya (tun daga watan Agusta 2020), nau'ikan nau'ikan bincike na asibiti ko na farko don haɓaka 'yan takarar warkewa na COVID-19 sun haɗa da:

* Antibodies ('yan takara 81)
* antiviral ('yan takara 31)
* mahadi na tushen cell ('yan takara 34)
* mahadi na tushen RNA ('yan takara 6)
* za a sake dawo da mahaɗan binciken ('yan takara 18)
* daban-daban sauran nau'o'in jiyya, irin su anti-mai kumburi, antimalarial, interferon, tushen furotin, maganin rigakafi, da mahadi masu daidaitawa.

Gwaje-gwajen Pivotal Phase III suna tantance ko maganin ɗan takarar yana da tasiri musamman akan cuta, kuma - a cikin yanayin mutanen da ke asibiti tare da cututtukan COVID-19 mai tsanani - gwada ingantaccen matakin kashi na wanda aka sake dawowa ko sabon ɗan takarar magani don inganta rashin lafiya (musamman ciwon huhu) daga kamuwa da cutar COVID-19. Don maganin da aka riga aka yarda da shi (kamar hydroxychloroquine don zazzabin cizon sauro), Gwajin Mataki na III-IV ya ƙayyade a cikin ɗaruruwa zuwa dubunnan mutanen da suka kamu da cutar ta COVID-19 yiwuwar tsawaita amfani da maganin da aka riga aka yarda da shi don magance kamuwa da COVID-19. Tun daga watan Agustan 2020, sama da magungunan ɗan takarar 500 sun kasance a cikin daidaitaccen tsari ko matakin ci gaban Mataki na I-IV, tare da sabbin gwaji na Mataki na II-III da aka sanar don ɗaruruwan 'yan takarar warkewa yayin 2020.

Yawancin magungunan 'yan takara da ke ƙarƙashin binciken a matsayin jiyya na "tallafawa" don kawar da rashin jin daɗi yayin rashin lafiya, irin su NSAIDs ko bronchodilators, ba a haɗa su a cikin teburin da ke ƙasa. Wasu a cikin gwaji na farko-farko na II ko kuma masu neman magani da yawa a cikin gwaje-gwajen Mataki na I, suma an cire su. 'Yan takarar ƙwayoyi a cikin gwaji na Mataki na I-II suna da ƙarancin nasara (a ƙarƙashin 12%) don wuce duk matakan gwaji don samun amincewa na ƙarshe. Da zarar an kai ga gwaji na Mataki na III, 'yan takarar warkewa don cututtukan da ke da alaƙa da kamuwa da cutar COVID-19 - cututtukan cututtuka da na numfashi - suna samun nasarar kusan kashi 72%.

## 'Yan takarar da aka sake dawo da su
Mayar da magunguna (kuma ana kiranta repurposing) - binciken magungunan da ake dasu don sabbin dalilai na warkewa - layin daya ne na binciken kimiyya da aka bi don haɓaka amintattun jiyya na COVID-19. Yawancin magungunan rigakafin ƙwayoyin cuta, waɗanda aka haɓaka a baya ko aka yi amfani da su azaman jiyya don matsanancin ciwo na numfashi mai tsanani (SARS), ciwo na numfashi na gabas ta tsakiya (MERS), HIV/AIDS, da zazzabin cizon sauro, ana binciken su azaman jiyya na COVID-19, tare da wasu ƙaura zuwa gwaji na asibiti.

A lokacin cutar ta COVID-19, sake fasalin ƙwayoyi shine tsarin bincike na asibiti na yin bincike cikin sauri da ma'anar aminci da ingancin magungunan da aka riga aka amince da su don wasu cututtukan da za a yi amfani da su ga mutanen da ke da kamuwa da COVID-19. A cikin tsarin haɓaka magunguna na yau da kullun, tabbatar da sake fasalin sabon maganin cutar zai ɗauki shekaru masu yawa na bincike na asibiti - gami da gwaji na asibiti na Mataki na III - akan magungunan ɗan takarar don tabbatar da amincin sa da ingancinsa musamman don magance kamuwa da COVID-19. A cikin gaggawa na cutar ta COVID-19 mai girma, ana haɓaka aikin sake dawo da magunguna a cikin Maris 2020 don kula da mutanen da ke asibiti tare da COVID-19.

Gwajin gwaji na asibiti ta amfani da maimaitawa, gabaɗaya amintattu, magungunan da ake da su don mutanen COVID-19 na asibiti na iya ɗaukar ɗan lokaci kaɗan kuma suna da ƙarancin ƙimar gabaɗaya don samun ƙarshen abubuwan da ke tabbatar da aminci (rashin sakamako masu illa ) da ingancin cutar bayan kamuwa da cuta, kuma yana iya shiga cikin sauri da wadatar wadatar magunguna. sarƙoƙi don masana'anta da rarraba duniya. A cikin ƙoƙarin ƙasa da ƙasa don kama waɗannan fa'idodin, WHO ta fara ne a tsakiyar Maris 2020 ta haɓaka gwaji na Mataki na II-III na ƙasa da ƙasa akan zaɓuɓɓukan magani huɗu masu ban sha'awa - gwajin SOLIDARITY - tare da sauran magunguna da yawa waɗanda ke da yuwuwar. repurposing a cikin daban-daban hanyoyin magance cututtuka, irin su anti-mai kumburi, corticosteroid, antibody, rigakafi, da kuma girma factor hanyoyin kwantar da hankali, da sauransu, ana ci gaba a cikin Phase II ko III gwaji a lokacin 2020.

A cikin Maris, Cibiyar Kula da Cututtuka da Cututtuka ta Amurka (CDC) ta ba da shawarar likita game da remdesivir ga mutanen da ke kwance a asibiti tare da cutar huhu da COVID-19 ke haifarwa: “Yayin da gwaje-gwajen asibiti suna da mahimmanci don tabbatar da aminci da ingancin wannan magani, likitocin ba tare da la’akari da su ba. samun damar yin gwajin asibiti na iya buƙatar remdesivir don amfanin jinƙai ta hanyar masana'anta don masu fama da ciwon huhu na asibiti."

## Duba kuma

* Kudin ci gaban miyagun ƙwayoyi

## Kara karantawa

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## Hanyoyin haɗi na waje

* R&D Blueprint da COVID-19, Hukumar Lafiya ta Duniya
* Coronaviruses ta Cibiyar Nazarin Allergy da Cututtuka ta Amurka
* COVID-19 therapeutics tracker Regulatory Affairs Professionals Society

## Manazarta